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Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices

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ClinicalTrials.gov Identifier: NCT01312519
Recruitment Status : Completed
First Posted : March 10, 2011
Results First Posted : July 23, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation

Study Description
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Brief Summary:
This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration system (OnControl by Vidacare) compared to traditional manual devices. The hypothesis is that the powered system will reduce the level of patient pain during the aspiration and core biopsy procedures and the amount of time needed to perform the procedures.

Condition or disease Intervention/treatment Phase
Bone Marrow Biopsy Procedures Device: OnControl Bone Marrow Biopsy and Aspiration System Device: Manual bone marrow sampling device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Manual bone marrow sampling device
Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection. Manual Bone Marrow Sampling Device.
 Device: Manual bone marrow sampling device
Hollow needle with a t-shaped handle that is pushed into the bone for the purpose of collecting bone marrow aspiration and core biopsy samples.
Other Names:
  • Jamshidi
  • Manual biopsy needle
Active Comparator: OnControl Bone Marrow System
Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest. OnControl Bone Marrow Biopsy and Aspiration System.
 Device: OnControl Bone Marrow Biopsy and Aspiration System
Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest for the purpose of aspiration and core biopsy collection.
Other Names:
  • OnControl
  • Powered Biopsy Device


Outcome Measures
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Primary Outcome Measures :
  1. Subject Reported Level of Pain During Procedure [ Time Frame: Day 1 during the needle insertion ]
    Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.


Secondary Outcome Measures :
  1. Time Necessary to Perform the Bone Marrow Procedure [ Time Frame: Day 1 needle insertion through needle removal ]
    The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over the age of 18
  • Patients that require core biopsy alone, or core biopsy and bone marrow aspiration

Exclusion Criteria:

  • Imprisoned
  • Pregnant
  • Cognitively impaired
  • Requiring english language translation other than Spanish
  • Patients with one or more conditions precluding bone marrow core biopsy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312519


Locations
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United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Sponsors and Collaborators
Vidacare Corporation
Investigators
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Study Director: Thomas Philbeck, PhD Vidacare Corporation
More Information
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Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01312519    
Other Study ID Numbers: 2007-04
First Posted: March 10, 2011    Key Record Dates
Results First Posted: July 23, 2013
Last Update Posted: August 7, 2013
Last Verified: July 2013
Keywords provided by Vidacare Corporation:
Bone marrow biopsy of iliac crest