NCT01312519CompletedNot Applicable
A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices
Vidacare Corporation4 sites in 2 countries50 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Subject Reported Level of Pain During Procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults over the age of 18
- •Patients that require core biopsy alone, or core biopsy and bone marrow aspiration
Exclusion Criteria
- •Imprisoned
- •Cognitively impaired
- •Requiring english language translation other than Spanish
- •Patients with one or more conditions precluding bone marrow core biopsy
Outcomes
Primary Outcomes
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 Outcomes
- Time Necessary to Perform the Bone Marrow Procedure(Day 1 needle insertion through needle removal)
Investigators
Study Sites (4)
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