| Registry | NCT03508674 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, other |
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| Enrollment | 54 (Actual) |
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| Sponsor | Levita Magnetics (Industry) |
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| Conditions | Bariatric Surgery Candidate |
|---|
| Interventions | Levita Magnetic Surgical System (Device) |
|---|
| Dates | start 2018-04-20, primary completion 2018-09-06, completion 2018-09-06, first posted 2018-04-26, last updated 2024-10-16 |
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| Locations | 1 site in Chile |
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All trials for Bariatric Surgery Candidate All trials of Levita Magnetic Surgical System
-Summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures
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+Detailed description
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Intervention | Experimental | Device: Levita Magnetic Surgical System | Levita Magnetic Surgical System |
- Levita Magnetic Surgical System (Device): use of surgical tool
+Outcome measures
Primary outcomes
- Number and Types of Additional Tools Required to Mobilize the Liver During Procedure [During planned bariatric procedure. (approximately 2 hours on a single day.)]: The ability to mobilize the liver will be evaluated by recording the number and types of additional tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful.
- Number of Participants With Adverse Events and Device Related Adverse Events [Through 30 days post bariatric procedure]: All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* at least 18 years of age
* scheduled to undergo bariatric procedure
Exclusion Criteria:
* Am Soc Anesthesiology score of III or IV
* significant comorbidities
* subjects contraindicated for use of magnetic system
* clinical history of impaired coagulation
* hepatic abnormality or anatomical abnormality
+Posted results
Participant flow
| Milestone | Intervention |
|---|
| Started | 54 |
| Completed | 50 |
| Not completed | 4 |
Outcome results
- Number and Types of Additional Tools Required to Mobilize the Liver During Procedure (Primary), Number, Additional Tools to Mobilize Liver: Intervention 0
- Number of Participants With Adverse Events and Device Related Adverse Events (Primary), Number, participants: Intervention 17
Adverse events
Time frame: 30 days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Intervention | 0/54 (0.0%) | 2/54 (3.7%) | 15/54 (27.8%) |
Serious adverse events by term
| Term | Organ system | Intervention |
|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | 1/54 |
| Abdominal Pain and Vomiting | Gastrointestinal disorders | 1/54 |
Other adverse events by term
| Term | Organ system | Intervention |
|---|
| Petechiae | Skin and subcutaneous tissue disorders | 8/54 |
| Liver Capsule Superficial Erosion Without Bleeding | Hepatobiliary disorders | 7/54 |
| Liver Capsule Superficial Abrasion Without Bleeding | Hepatobiliary disorders | 2/54 |
| Ecchymosis | Skin and subcutaneous tissue disorders | 2/54 |
| Hepatic Hematoma | Hepatobiliary disorders | 1/54 |
| Acute Gastroenteritis | Gastrointestinal disorders | 1/54 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Hospital La Florida | Santiago | Chile | |
+Publications
- Results publication: Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodriguez Del Rey M, Davanzo C, Portenier D, Guerron AD. First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis. 2021 Jan;17(1):147-152. doi: 10.1016/j.soard.2020.08.017. Epub 2020 Aug 26. PMID 33011073
+Study documents
+Investigators