A Randomized, Single Blind, Uni-centre Study in Healthy Volunteers, to Determine Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets
| Registry | NCT03752229 |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 300 (Actual) |
| Sponsor | HTL-Strefa S.A. (Industry) |
| Conditions | Healthy |
| Interventions | Acti-Lance Lite, Acti-Lance Universal, Acti-Lance Special, Medlance Plus Super Lite, Medlance Plus Lite, Medlance Plus Universal, Medlance Plus Extra, Medlance Plus Special, Prolance Micro Flow, Prolance Low Flow, Prolance Normal Flow, Prolance High Flow, Prolance Max Flow, Prolance Pediatric, Haemolance Micro Flow, Haemolance Low Flow, Haemolnace Normal Flow, Haemolance High Flow, Haemolance Max Flow, Haemolance Pediatric, MediSafe Solo 29 Gauge, MediSafe Solo 23 Gauge, ergoLance Micro Flow, ergoLance Normal Flow, ergoLance High Flow, Medlance (light blue), Medlance (blue), Medlance (dark blue), Medlance (yellow), Medlance (orange), Medlance (red), Unistik 3 Extra, Unistik 3 Comfort, Unistik Touch, ReadyLance (blue), ReadyLance (orange), AssureLance, AssureLance MicroFlow, Surgilance, Surgilance Lite (grey), Surgilance Lite (purple), SteriLance Lite2, SensiLance (pink), SteriLance Press, SensiLance (orange), mylife, VeriFine, Microdot (Device) |
| Dates | start 2017-12-08, primary completion 2017-12-17, completion 2018-01-30, first posted 2018-11-23, last updated 2018-11-26 |
| Locations | 1 site in Poland |
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-Summary
The study was a randomized, single blind, uni-center pivotal study in male and female healthy volunteers, to determine capillary blood volume and pain perception obtained in a process of puncturing with different safety lancets.
A group of three hundred (300) Caucasian male and female Subjects was randomized (aged > 18 to < 65 years old) who were in good physical and mental condition. The Subjects had 4 (four) fingers (two fingers from each hand) lanced each with a different type of safety lancet. Overall, 4 (four) different safety lancets were investigated per each Subject.
Overall, 48 (forty eight) different safety lancets (4 different safety lancets per one Subject) were investigated, the capillary blood volume and pain were measured.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| HTL-STREFA S.A.safety lancet type 610 | Experimental | Device: Acti-Lance Lite; Device: Acti-Lance Universal; Device: Acti-Lance Special | |
| HTL-STREFA S.A.safety lancet type 553-556 | Experimental | Device: Medlance Plus Super Lite; Device: Medlance Plus Lite; Device: Medlance Plus Universal; Device: Medlance Plus Extra; Device: Medlance Plus Special | |
| HTL-STREFA S.A.safety lancet type 430 | Experimental | Device: Prolance Micro Flow; Device: Prolance Low Flow; Device: Prolance Normal Flow; Device: Prolance High Flow; Device: Prolance Max Flow; Device: Prolance Pediatric | |
| HTL-STREFA S.A.safety lancet type 420 | Experimental | Device: Haemolance Micro Flow; Device: Haemolance Low Flow; Device: Haemolnace Normal Flow; Device: Haemolance High Flow; Device: Haemolance Max Flow; Device: Haemolance Pediatric | |
| HTL-STREFA S.A.safety lancet type 520 | Experimental | Device: MediSafe Solo 29 Gauge; Device: MediSafe Solo 23 Gauge | |
| HTL-STREFA S.A.safety lancet type 450 | Experimental | Device: ergoLance Micro Flow; Device: ergoLance Normal Flow; Device: ergoLance High Flow | |
| HTL-STREFA S.A.safety lancet type 545-549 | Experimental | Device: Medlance (light blue); Device: Medlance (blue); Device: Medlance (dark blue); Device: Medlance (yellow); Device: Medlance (orange); Device: Medlance (red) | |
| Owem Mumford lancet | Experimental | Device: Unistik 3 Extra; Device: Unistik 3 Comfort; Device: Unistik Touch | |
| Medicore lancet | Experimental | Device: ReadyLance (blue); Device: ReadyLance (orange) | |
| Arkray lancet | Experimental | Device: AssureLance; Device: AssureLance MicroFlow | |
| Medipurpose lancet | Experimental | Device: Surgilance; Device: Surgilance Lite (grey); Device: Surgilance Lite (purple) | |
| Sterilance lancet | Experimental | Device: SteriLance Lite2; Device: SteriLance Press | |
| Dynarex lancet | Experimental | Device: SensiLance (pink); Device: SensiLance (orange) | |
| Ypsomed lancet | Experimental | Device: mylife | |
| Promismed lancet | Experimental | Device: VeriFine | |
| Cambridge Sensors lancet | Experimental | Device: Microdot | |
- Acti-Lance Lite (Device), also known as HTL-STREFA S.A. safety lancet type 610: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Acti-Lance Universal (Device), also known as HTL-STREFA S.A. safety lancet type 610: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Acti-Lance Special (Device), also known as HTL-STREFA S.A. safety lancet type 610: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance Plus Super Lite (Device), also known as HTL-STREFA S.A. safety lancet type 553: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance Plus Lite (Device), also known as HTL-STREFA S.A. safety lancet type 553: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance Plus Universal (Device), also known as HTL-STREFA S.A. safety lancet type 554: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance Plus Extra (Device), also known as HTL-STREFA S.A. safety lancet type 555: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance Plus Special (Device), also known as HTL-STREFA S.A. safety lancet type 556: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Prolance Micro Flow (Device), also known as HTL-STREFA S.A. safety lancet type 430: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Prolance Low Flow (Device), also known as HTL-STREFA S.A. safety lancet type 430: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Prolance Normal Flow (Device), also known as HTL-STREFA S.A. safety lancet type 430: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Prolance High Flow (Device), also known as HTL-STREFA S.A. safety lancet type 430: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Prolance Max Flow (Device), also known as HTL-STREFA S.A. safety lancet type 430: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Prolance Pediatric (Device), also known as HTL-STREFA S.A. safety lancet type 430: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Haemolance Micro Flow (Device), also known as HTL-STREFA S.A. safety lancet type 420: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Haemolance Low Flow (Device), also known as HTL-STREFA S.A. safety lancet type 420: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Haemolnace Normal Flow (Device), also known as HTL-STREFA S.A. safety lancet type 420: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Haemolance High Flow (Device), also known as HTL-STREFA S.A. safety lancet type 420: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Haemolance Max Flow (Device), also known as HTL-STREFA S.A. safety lancet type 420: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Haemolance Pediatric (Device), also known as HTL-STREFA S.A. safety lancet type 420: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- MediSafe Solo 29 Gauge (Device), also known as HTL-STREFA S.A. safety lancet type 520: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- MediSafe Solo 23 Gauge (Device), also known as HTL-STREFA S.A. safety lancet type 520: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- ergoLance Micro Flow (Device), also known as HTL-STREFA S.A. safety lancet type 450: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- ergoLance Normal Flow (Device), also known as HTL-STREFA S.A. safety lancet type 450: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- ergoLance High Flow (Device), also known as HTL-STREFA S.A. safety lancet type 450: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance (light blue) (Device), also known as HTL-STREFA S.A. safety lancet type 545: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance (blue) (Device), also known as HTL-STREFA S.A. safety lancet type 545: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance (dark blue) (Device), also known as HTL-STREFA S.A. safety lancet type 546: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance (yellow) (Device), also known as HTL-STREFA S.A. safety lancet type 547: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance (orange) (Device), also known as HTL-STREFA S.A. safety lancet type 548: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Medlance (red) (Device), also known as HTL-STREFA S.A. safety lancet type 549: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Unistik 3 Extra (Device), also known as Owem Mumford lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Unistik 3 Comfort (Device), also known as Owem Mumford lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Unistik Touch (Device), also known as Owem Mumford lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- ReadyLance (blue) (Device), also known as Medicore lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- ReadyLance (orange) (Device), also known as Medicore lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- AssureLance (Device), also known as Arkray lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- AssureLance MicroFlow (Device), also known as Arkray lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Surgilance (Device), also known as Medipurpose lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Surgilance Lite (grey) (Device), also known as Medipurpose lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Surgilance Lite (purple) (Device), also known as Medipurpose lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- SteriLance Lite2 (Device), also known as Sterilance lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- SensiLance (pink) (Device), also known as Dynarex lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- SteriLance Press (Device), also known as Sterilance lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- SensiLance (orange) (Device), also known as Dynarex lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- mylife (Device), also known as Ypsomed lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- VeriFine (Device), also known as Promismed lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
- Microdot (Device), also known as Cambridge Sensors lancet: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
+Outcome measures
Primary outcomes
- Volume (microliters) of blood in the capillary tube [The blood volume was noted after 20 seconds]: The amount of capillary blood volume collected after a single lancing of the fingertip.
- Volume (microliters) of blood in the capillary tube [The blood volume was noted until the end of bleeding or up to 2 minutes time]: The amount of capillary blood volume collected after a single lancing of the fingertip.
Secondary outcomes
- Pain perception [directly after lancing]: The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 ("no pain") to 10 ("worst imaginable pain") that represented their perception of pain. A higher score indicated greater pain intensity.
- Pain perception [after 30 minutes ± 5 min after lancing]: The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 ("no pain") to 10 ("worst imaginable pain") that represented their perception of pain. A higher score indicated greater pain intensity.
+Eligibility
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria:
* Willing to sign the informed consent.
* Male and female volunteers
* Age between 18 and 65 inclusive
* Able to communicate well with the Investigator and comply with the requirements of the study
* Volunteers who are in good physical and mental health
Exclusion Criteria:
* Confirmed or suspected malignant cancer
* Pregnancy or breastfeeding (only for women with childbearing potential based on pregnancy test conducted at Site)
* History of poor blood circulation.
* Any skin condition on his or her fingers that prevents blood sampling
* Anxiety with needles or finger pricks
* Clotting disorders (including bleeding) in medical history
* Neuropathy or other condition affecting sensation in the hands.
* History of blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease)
* Currently participating in another study
* History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse
* Intake of alcohol within 48 hours prior to the start of the study (self-reporting)
* Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study
* Any other condition that in the Investigator opinion may negatively influence Subject's participation in the study
* Intake of medicines that affect blood coagulability (including anticoagulants such as vitamin K, antivirals and anticoagulants such as heparin, aspirin, thrombin inhibitors, vitamin K antagonists).
+Locations (1)
| Facility | City | Country | Status |
|---|
| BioResearch Group Sp. z o.o. | Nadarzyn, Masovian Voivodeship | Poland | |