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

NCT ID: NCT01535313

Last Updated: 2012-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Bone Marrow Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Manual (Hospital Systems TRAP Needle)

Bone marrow biopsy with a standard manual system

Group Type ACTIVE_COMPARATOR

OnControl BM-Biopsy system

Intervention Type DEVICE

Bone marrow biopsy at posterior iliac crest

Powered

Group Type EXPERIMENTAL

OnControl BM-Biopsy system

Intervention Type DEVICE

Bone marrow biopsy at posterior iliac crest

Interventions

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OnControl BM-Biopsy system

Bone marrow biopsy at posterior iliac crest

Intervention Type DEVICE

Other Intervention Names

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http://www.vidacare.com/OnControl/Bone-Marrow-Clinicians.aspx http://www.hsmedicalinc.com/

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph M Bucher, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Biopsycontrol

Identifier Type: -

Identifier Source: org_study_id

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