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

University Hospital Basel

Status: Completed

Conditions: Bone Marrow Biopsy

Treatments: Device: OnControl BM-Biopsy system

Study type: Interventional

Funder types: Other

Identifiers

NCT01535313

Biopsycontrol

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Manual (Hospital Systems TRAP Needle)

Active Comparator group

Description:

Bone marrow biopsy with a standard manual system

Treatment:

Device: OnControl BM-Biopsy system

Powered

Experimental group

Treatment:

Device: OnControl BM-Biopsy system