Reciprocating Medical Devices - a Study of a New Safety Device

Study Overview
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Brief Summary
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The study design is a randomized study to directly compare the performance and the outcome of syringe and needle procedures with a standard syringe or the new reciprocating procedure device (RDP), which is a type of safety syringe. Over a 5 year period, 820 subjects who require and assent to a syringe and needle procedure for their usual and customary care will be randomized to either a conventional syringe or the RPD with one arm with and without ultrasound guidance. The RPD is designed to be safer, faster, less painful, and more effective for the patient, and the mechanics of the RPD are intended to provide the physician with better needle control, resulting in less needle trauma to patient tissues, and thus, reduced bleeding and pain for the patient. This clinical trial will address whether the RPD is indeed superior to the conventional syringe for shots, injections, and needle procedures, and whether it is a safer, less painful syringe.

Detailed Description
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* 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.

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

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Trauma, Thyroid Nodule, Cancer

Intervention / Treatment
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* Device: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001
* Device: conventional syringe - BD Ref 309604


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A syringe and needle procedure is required for the normal customary care of the patient Exclusion Criteria: hemorrhagic diathesis, use of anticoagulants and antiplatelet agents child or susceptible population

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The intervention is the use of the reciprocating procedure device (RPD) (AVANCA Re No. 1091001) (intervention) (Arm 1) with and without ultrasound guidance (intervention) in a syringe and needle procedure in comparison to a conventional syringe (BD Ref 309604) (control, Arm 2). | Device: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001<br>* The RPD is a safety syringe device that is hypothesized to be safer, less painful, and more effective for patients undergoing a syringe and needle procedure (please see arm #1).<br>* Other names: AVANCA RPD;|
| Active Comparator: 2<br>The conventional syringe (BD Ref 309604) is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined) and compared to Arm 1. | Device: conventional syringe - BD Ref 309604<br>* the conventional syringe or the RPD will be used for syringe and needle procedures performed by physicians.<br>* Other names: traditional syringe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Using VAS (Visual Analogue Pain Scale) | 0-10 cm VAS pain scale at 2 weeks compared to 0-10 cm VAS pain scale at 0 weeks where 0= no pain, and 10 = the worst pain imaginable. The difference (2 week VAS-0 week VAS) is the primary outcome measure. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspirated Fluid Volume | Aspirated fluid volume during procedure | during procedure | 
| Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation) |  | during procedure, 2 weeks afterwards, and 6 months afterwards | 
| Physician Satisfaction | 0- 10 cm visual analogue satisfaction scale (VASS) 0-10 cm VASS at 2 weeks compared to 0-10 cm VASS pain scale at 0 weeks where 0= completely dissatisfied, and 10 = completely satsified. The difference (2 week VAS-0 week VAS) is the outcome measure | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthrocentesis, injections, anesthesia, biopsy, aspiration, syringe, safety, pain