A Randomized Trial Evaluating a New Powered Bone Marrow Aspirate and Core Biopsy System Compared to Traditional Manual Devices.

Abstract 4234

Traditional bone marrow procedures using a manual device hand-inserted by the clinician may be associated with pain, bleeding and inability to obtain adequate specimens leading to multiple attempts and a prolonged time to complete the procedure. These procedures take from approximately 7 minutes to more than 30 minutes to collect adequate aspirate and core biopsy samples. Notably, it has been shown that the duration of needle insertion is the sole predictor of patient pain during the procedure. In an attempt to overcome these shortcomings of the traditional technique, the OnControl bone marrow aspiration and biopsy system has recently been developed. It is an FDA-cleared device, comprised of the driver, a metal needle set and a connector. The driver is a small battery-powered device for insertion of a single lumen needle into the intraosseous space of the adult iliac crest. This device allows for a minimally-invasive procedure that in a 2007 study showed a substantially faster time for needle insertion into the medullary space of the iliac crest with a mean insertion time of 5 seconds. In an interim analysis of a single-arm validation study for the OnControl system, 36 patient procedures were completed with a mean user satisfaction score of 4.6 (on a scale of 0-5, with 5 indicating high satisfaction), a biopsy core acquisition success rate of 92%, a mean length of biopsy core of 1.22 cm, and a mean time from needle insertion to core extraction of 2 minutes and 9 seconds. Thus, we are currently enrolling patients on a multicenter, prospective, randomized controlled trial in order to directly compare results of using this new powered core biopsy needle to traditional manually inserted needles in terms of patient level of pain, time from needle insertion to removal, insertion success rate, core biopsy capture rate, quality of yield of this device, rate of complications, and operator satisfaction with the device. Patients requiring conscious sedation/narcotics for pain relief or extra bone marrow for research purposes/additional tests beyond that required for routine clinical evaluation will be excluded. Block randomization with blocks of size 4 will be used to prevent unequal treatment-group sizes. Each patient is being randomized to undergo a bone marrow procedure with the standard manual device or the powered device. Patient pain is being assessed using the Visual Analog Scale of 0 to 10; with 0 = no pain and 10 = extreme pain. The pain level will be assessed immediately following needle removal and at days 2 and 8 following the procedure. We plan to enroll 102 patients in this study and expect to have all patients enrolled in the next 3 months. Updated data as part of an interim analysis of this randomized trial will be presented at the time of the ASH meeting.