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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01535313

Enrollment

Registered

2012-02-17

Start date

2011-05-31

Completion date

2011-12-31

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Biopsy

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.

Interventions

DEVICEOnControl BM-Biopsy system

Bone marrow biopsy at posterior iliac crest

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026