Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices - Full Text View

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: Patient is only followed for the time it takes to perform the bone marrow procedure (less than 24 hrs). No additonal follow up is required. ] [ Designated as safety issue: No ]
Subjects were asked to rate the level of pain they expereinced during the procedure at two specific time points: 1)for needle insertion, following penetration of the cortex, and 2)following removal of the needle from the patient for an overall pain score.

Secondary Outcome Measures:

Time necessary to perform the bone marrow procedure [ Time Frame: Patient is followed only for the time necessary to perform the bone marrow procedure (less than 24 hrs). No additional patient follow up is required. ] [ 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.	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.	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

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:	Thomas Phibeck/ Director of Science and Clinical, Vidacare Corporation
ClinicalTrials.gov Identifier:	NCT01312519 History of Changes
Other Study ID Numbers:	2007-04
Study First Received:	November 3, 2010
Last Updated:	March 8, 2011
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 May 16, 2013