NCT01535313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

February 9, 2012

Last Update Submit

February 16, 2012

Conditions

Bone Marrow Biopsy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • patient pain during procedure

    day 1 (two time points) and day 3-5

Study Arms (2)

Manual (Hospital Systems TRAP Needle)

ACTIVE COMPARATOR

Bone marrow biopsy with a standard manual system

Device: OnControl BM-Biopsy system

Powered

EXPERIMENTAL
Device: OnControl BM-Biopsy system

Interventions

OnControl BM-Biopsy systemDEVICE

Bone marrow biopsy at posterior iliac crest

Also known as: http://www.vidacare.com/OnControl/Bone-Marrow-Clinicians.aspx, http://www.hsmedicalinc.com/
Manual (Hospital Systems TRAP Needle)Powered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18
  • \>= one previous bone marrow procedure
  • INR \> 1.4
  • tThrombocyte count \> 10 x109/l
  • informed consent signed

You may not qualify if:

  • cognitive impairment
  • excessive tissue at anatomical landmarks
  • BMI \> 35 kg/m2
  • allergy to premedication
  • unable to lay flat in prone position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4032, Switzerland

Location

Study Officials

  • Christoph M Bucher, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 17, 2012

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

CH(1)