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Reciprocating Medical Devices - a Study of a New Safety Device

NCT00651625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2016-03-02

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001

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).

DEVICE

conventional syringe - BD Ref 309604

the conventional syringe or the RPD will be used for syringe and needle procedures performed by physicians.

Sponsors & Collaborators

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Wilmer L Sibbitt, Jr., MD · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2010-01-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00651625 on ClinicalTrials.gov