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N/A N=437 Randomized Single-blind Treatment

Reciprocating Medical Devices - a Study of a New Safety Device

Osteoarthritis · Rheumatoid Arthritis · Trauma · Thyroid Nodule · Cancer

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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