Reciprocating Medical Devices - a Study of a New Safety Device

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT00651625

Run by

University of New Mexico

People needed

437

Starts

2004-11-01

Expected to finish

2010-08-01

Last updated by the study team

2016-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A syringe and needle procedure is required for the normal customary care of the patient

You may not qualify if…

• hemorrhagic diathesis,
• use of anticoagulants and antiplatelet agents child or susceptible population

Where it is running

• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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