N/A
N=437
Reciprocating Medical Devices - a Study of a New Safety Device
Osteoarthritis · Rheumatoid Arthritis · Trauma · Thyroid Nodule · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00651625 ↗Enrolled (actual)
437
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Pain Using VAS (Visual Analogue Pain Scale) — 5.2; 6.2 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001 (Device); conventional syringe - BD Ref 309604 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Using VAS (Visual Analogue Pain Scale) |
5.2; 6.2 | — |
| SECONDARY Aspirated Fluid Volume |
7.2; 14.5 | — |
| SECONDARY Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation) |
0; 0 | — |
| SECONDARY Physician Satisfaction |
6.4; 8.5 | 0.05 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00651625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.