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

Bone Marrow Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535313
• Other study ID #: Biopsycontrol
• Status: Completed
• Phase: N/A
• First received: February 9, 2012
• Last updated: February 16, 2012
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Marrow Biopsy

Intervention

Device:
• OnControl BM-Biopsy system
Bone marrow biopsy at posterior iliac crest

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic usefulness (yes/no) of biopsy cylinder	The bone marrow biopsy cylinder is assessed by a pathologist who rates either "diagnostic" or "non diagnostic"	within 1 week of biopsy	No
Secondary	patient pain during procedure	patients underdoing biopsy rate the pain during, 15 min after and 3-5 days after the proceedure	day 1 (two time points) and day 3-5	No