A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
subject reported level of pain during procedure
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.
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.
Thomas Philbeck, PhD
United States: Institutional Review Board
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