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

Not Applicable

Completed

• Conditions: Bone Marrow Biopsy
• Interventions: Device: OnControl BM-Biopsy system

• Registration Number: NCT01535313
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-02
• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-16
• Last Update Submitted: 2012-02-16
• Study First Posted: 2012-02-17
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual (Hospital Systems TRAP Needle)	OnControl BM-Biopsy system	Bone marrow biopsy with a standard manual system
Powered	OnControl BM-Biopsy system	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, BS, Switzerland