Comparison of a Powered Bone Marrow Biopsy Device With a Manual System

NCT01535313 — Not applicable, Completed, 60 participants, University Hospital, Basel, Switzerland

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a Prospective Randomized Controlled Trial Comparing a Powered Bone Marrow Biopsy Device With a Manual System

Registry	NCT01535313
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, diagnostic
Enrollment	60 (Actual)
Sponsor	University Hospital, Basel, Switzerland (Other)
Conditions	Bone Marrow Biopsy
Interventions	OnControl BM-Biopsy system (Device)
Dates	start 2011-05-01, primary completion 2011-09-01, completion 2011-12-01, first posted 2012-02-17, last updated 2012-02-17
Locations	1 site in Switzerland

-Summary

Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness is improved with a powered bone marrow biopsy device in comparison with a manual device.

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+Arms and interventions

Arm	Type	Interventions	Description
Manual (Hospital Systems TRAP Needle)	Active comparator	Device: OnControl BM-Biopsy system	Bone marrow biopsy with a standard manual system
Powered	Experimental	Device: OnControl BM-Biopsy system

OnControl BM-Biopsy system (Device), also known as http://www.vidacare.com/OnControl/Bone-Marrow-Clinicians.aspx, http://www.hsmedicalinc.com/: Bone marrow biopsy at posterior iliac crest

+Outcome measures

Primary outcomes

Diagnostic usefulness (yes/no) of biopsy cylinder [within 1 week of biopsy]: The bone marrow biopsy cylinder is assessed by a pathologist who rates either "diagnostic" or "non diagnostic"

Secondary outcomes

patient pain during procedure [day 1 (two time points) and day 3-5]: patients underdoing biopsy rate the pain during, 15 min after and 3-5 days after the proceedure

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* age > 18
* >= one previous bone marrow procedure
* INR > 1.4
* tThrombocyte count > 10 x109/l
* informed consent signed

Exclusion Criteria:

* cognitive impairment
* excessive tissue at anatomical landmarks
* BMI > 35 kg/m2
* allergy to premedication
* unable to lay flat in prone position

+Locations (1)

Facility	City	Country	Status
University Hospital Basel	Basel, Canton of Basel-City	Switzerland

+Investigators

Christoph M Bucher, MD, Principal investigator, University Hospital, Basel, Switzerland