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A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices


N/A
18 Years
N/A
Not Enrolling
Both
Bone Marrow Biopsy Procedures

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Trial Information

A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

subject reported level of pain during procedure

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Thomas Philbeck, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Vidacare Corporation

Authority:

United States: Institutional Review Board

Study ID:

2007-04

NCT ID:

NCT01312519

Start Date:

January 2010

Completion Date:

August 2010

Related Keywords:

  • Bone Marrow Biopsy Procedures
  • Bone marrow biopsy of iliac crest

Name

Location

Cancer Therapy and Research Center San Antonio, Texas  78229