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OpenTrials
Completed

NCT Number: NCT01535313

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

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.

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Key information

Conditions

Bone Marrow Biopsy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OnControl BM-Biopsy system

Device

Bone marrow biopsy at posterior iliac crest

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

Primary outcomes

  1. Diagnostic usefulness (yes/no) of biopsy cylinder

    Time frame: within 1 week of biopsy

    The bone marrow biopsy cylinder is assessed by a pathologist who rates either "diagnostic" or "non diagnostic"

Secondary outcomes

  1. patient pain during procedure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2012
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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