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NCT00651625 · ClinicalTrials.gov registry record · NA
Reciprocating Medical Devices - a Study of a New Safety Device
A NA study, sponsored by University of New Mexico.
- Completed
- Registry status
- NA
- Development phase
- 437
- Enrollment target
NCT00651625: Completed NA study, sponsored by University of New Mexico.
NCT00651625 is a NA study that has completed, run by University of New Mexico. The registered enrollment target is 437 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00651625, a NA study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- NA
- Development phase
- 437 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001
- DEVICE conventional syringe - BD Ref 309604
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2004-11 |
| Est. Completion | 2010-08 |
| Phase | NA |
What the finished NCT00651625 record still lists
NCT00651625 is an interventional study that assigns participants to a tested intervention. The registered 437 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001 is the first listed.
NCT00651625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00651625 about?
NCT00651625 is a clinical study titled "Reciprocating Medical Devices - a Study of a New Safety Device". 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 syrin...
What is the current status of trial NCT00651625?
This trial is currently completed. It is a NA study. The enrollment target is 437 participants. The study started on 2004-11. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00651625?
The interventions under investigation include: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001 (DEVICE), conventional syringe - BD Ref 309604 (DEVICE).
Who is sponsoring clinical trial NCT00651625?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00651625's enrollment target sits among peer trials
437 235th of 2000 higher than 1,766 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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