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

NCT01312519 | Completed Results

• 1 other identifier: 2007-04
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Bone Marrow Biopsy Procedures

Keywords

Bone marrow biopsy of iliac crest

Outcome Measures

Primary Outcomes (1)

• Subject Reported Level of Pain During Procedure

  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.

  Day 1 during the needle insertion

Secondary Outcomes (1)

• Time Necessary to Perform the Bone Marrow Procedure

  Day 1 needle insertion through needle removal

Study Arms (2)

Manual bone marrow sampling device

ACTIVE COMPARATOR

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

OnControl Bone Marrow System

ACTIVE COMPARATOR

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

Interventions

OnControl Bone Marrow Biopsy and Aspiration System DEVICE

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.

Also known as: OnControl, Powered Biopsy Device

OnControl Bone Marrow System

Manual bone marrow sampling device 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.

Also known as: Jamshidi, Manual biopsy needle

Manual bone marrow sampling device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Imprisoned
• Pregnant
• Cognitively impaired
• Requiring english language translation other than Spanish
• Patients with one or more conditions precluding bone marrow core biopsy

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (2)

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Results Point of Contact

• Title: Senior Director of Science and Clinical
• Organization: Vidacare Corporation

thomas.philbeck@vidacare.com

210-375-8500

Study Officials

• Thomas Philbeck, PhD

  Vidacare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: March 10, 2011
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 24, 2025
• Results First Posted: July 23, 2013

Record last verified: 2013-07

Locations

ES (1); US (1)