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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation
ClinicalTrials.gov Identifier:
NCT01312519
First received: November 3, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention
Bone Marrow Biopsy Procedures
Device: OnControl Bone Marrow Biopsy and Aspiration System
Device: Manual bone marrow sampling device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Vidacare Corporation:

Primary Outcome Measures:
  • Subject Reported Level of Pain During Procedure [ Time Frame: Day 1 during the needle insertion ] [ Designated as safety issue: No ]
    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:
  • Time Necessary to Perform the Bone Marrow Procedure [ Time Frame: Day 1 needle insertion through needle removal ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312519

Locations
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
Study Director: Thomas Philbeck, PhD Vidacare Corporation
  More Information

No publications provided

Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01312519     History of Changes
Other Study ID Numbers: 2007-04
Study First Received: November 3, 2010
Results First Received: February 28, 2013
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board
Spain: Ethics Committee

Keywords provided by Vidacare Corporation:
Bone marrow biopsy of iliac crest

ClinicalTrials.gov processed this record on August 25, 2014