Trial Information

Randomized Controlled Trial of the Reciprocating Procedure Device Versus the Conventional Syringe in Syringe-and-Needle Procedures

* BACKGROUND

The syringe is an ancient device designed principally to inject medications. However,
because of the inherent biomechanics of the human hand and the interaction of the hand with
the piston, the syringe is very stable and easily controlled the injection phase, but is
extremely unstable and difficult to control in the aspiration phase. New reciprocating
technology that accommodates the biomechanics of hand function has great promise of
improving the stability and safety of hand-held devices, including procedure syringes.

* EXPERIMENTAL DESIGN AND METHODS

The study design is a randomized study to directly compare the performance and the outcome
of syringe and needle procedures accomplished either with a standard syringe or the new
reciprocating procedure device (RDP). Over a 5 year period, 820 subjects who require and
assent to a syringe procedure for their usual and customary care will be randomized to
either a conventional syringe or the reciprocating syringe. The following syringe
procedures will be studied: 1) local anesthesia, 2) centesis (arthrocentesis, paracentesis,
thoracentesis, amniocentesis, pericardiocentesis), 3) aspiration and puncture (aspiration of
bursa, cyst, abscess, shunt, bone marrow, and other syringe aspiration procedures), 4)
injection of a therapeutic or diagnostic substance into a joint, bursa, vessel, or other
body structure, 5) fine needle biopsy with syringe vacuum of a mass or tissue, 6)
irrigation procedures (wound, bladder, and other irrigation procedures), and 7) vascular
access (introduction of a wire, catheter, or sheath into a blood vessel), and 8) with and
without ultrasound guidance.

In a subject with multiple individual procedure sites, or requires multiple separate
biopsies, each will be randomized between the two syringes, and each biopsy or fluid sample
will be analyzed separately (as is medically appropriate). The physicians who will perform
the syringe procedures will be those physicians who usually perform the syringe procedures
and are credentialed to do so. Outcome data collection will occur first by one of the
investigators observing the procedure and collecting the data by real time interview and by
chart review including cost analysis. Outcome data will include effectiveness (preprocedural
pain, pain at 2 weeks post procedure, and pain at 6 months postprocedure), procedure time,
patient pain, operator satisfaction, trauma to tissues, complications, diagnostic yield,
overall medical care costs and hospital stay. Retrospective review of 30 charts of the
device used clinically has also been approved (2006). Analysis of data will be performed by
a statistician blinded to treatment group.

*SIGNIFICANCE: The proposed study will be the first to study the clinical performance
characteristics of a medical device that incorporates the new reciprocating technology
designed to take advantage of the inherent biomechanical stability characteristics of the
human hand. The preclinical studies presented in the preliminary data demonstrate markedly
enhanced device performance characteristics, and much greater control and stability,
strongly suggesting that reciprocating devices will be safer, more effective, more
economical, and provide better patient outcomes.