Reciprocating Medical Devices - a Study of a New Safety Device (RPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00651625
First received: March 21, 2008
Last updated: February 13, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention
Osteoarthritis
Rheumatoid Arthritis
Trauma
Thyroid Nodule
Cancer
Device: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001
Device: conventional syringe - BD Ref 309604

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Reciprocating Procedure Device Versus the Conventional Syringe in Syringe-and-Needle Procedures

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Pain (Visual Analogue Pain Scale) [ Time Frame: Prior to procedure, during procedure, 2 weeks after procedure, and 6 months after procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aspirated fluid volume [ Time Frame: during procedure ] [ Designated as safety issue: No ]
  • adverse outcomes (hemorrhage, infection, hematoma, extravasation) [ Time Frame: during procedure, 2 weeks afterwards, and 6 months afterwards ] [ Designated as safety issue: Yes ]
  • Physician Satisfaction [ Time Frame: during procedure ] [ Designated as safety issue: No ]

Enrollment: 437
Study Start Date: November 2004
Study Completion Date: August 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
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).
Other Name: AVANCA RPD
Active Comparator: 2
Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
Device: conventional syringe - BD Ref 309604
the conventional syringe or the RPD will be used for syringe and needle procedures performed by physicians.
Other Names:
  • syringe
  • conventional syringe
  • traditional syringe

Detailed Description:

* BACKGROUND

The syringe is an ancient device designed principally to inject medications. However, because of the inherent biomechanics of the human hand and the interaction of the hand with the piston, the syringe is very stable and easily controlled the injection phase, but is extremely unstable and difficult to control in the aspiration phase. New reciprocating technology that accommodates the biomechanics of hand function has great promise of improving the stability and safety of hand-held devices, including procedure syringes.

* EXPERIMENTAL DESIGN AND METHODS

The study design is a randomized study to directly compare the performance and the outcome of syringe and needle procedures accomplished either with a standard syringe or the new reciprocating procedure device (RDP). Over a 5 year period, 820 subjects who require and assent to a syringe procedure for their usual and customary care will be randomized to either a conventional syringe or the reciprocating syringe. The following syringe procedures will be studied: 1) local anesthesia, 2) centesis (arthrocentesis, paracentesis, thoracentesis, amniocentesis, pericardiocentesis), 3) aspiration and puncture (aspiration of bursa, cyst, abscess, shunt, bone marrow, and other syringe aspiration procedures), 4) injection of a therapeutic or diagnostic substance into a joint, bursa, vessel, or other body structure, 5) fine needle biopsy with syringe vacuum of a mass or tissue, 6) irrigation procedures (wound, bladder, and other irrigation procedures), and 7) vascular access (introduction of a wire, catheter, or sheath into a blood vessel), and 8) with and without ultrasound guidance.

In a subject with multiple individual procedure sites, or requires multiple separate biopsies, each will be randomized between the two syringes, and each biopsy or fluid sample will be analyzed separately (as is medically appropriate). The physicians who will perform the syringe procedures will be those physicians who usually perform the syringe procedures and are credentialed to do so. Outcome data collection will occur first by one of the investigators observing the procedure and collecting the data by real time interview and by chart review including cost analysis. Outcome data will include effectiveness (preprocedural pain, pain at 2 weeks post procedure, and pain at 6 months postprocedure), procedure time, patient pain, operator satisfaction, trauma to tissues, complications, diagnostic yield, overall medical care costs and hospital stay. Retrospective review of 30 charts of the device used clinically has also been approved (2006). Analysis of data will be performed by a statistician blinded to treatment group.

*SIGNIFICANCE: The proposed study will be the first to study the clinical performance characteristics of a medical device that incorporates the new reciprocating technology designed to take advantage of the inherent biomechanical stability characteristics of the human hand. The preclinical studies presented in the preliminary data demonstrate markedly enhanced device performance characteristics, and much greater control and stability, strongly suggesting that reciprocating devices will be safer, more effective, more economical, and provide better patient outcomes.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651625

Locations
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Wilmer L Sibbitt, Jr., MD University of New Mexico
  More Information

Publications:
Michael AA, Park KS, Moorjani GR, Peisjovich A, Sibbitt WL Jr., Bankhurst AD: Syringe size: Does it matter in physician performed procedures?. Journal of Clinical Rheumatology 2008 (In Press).
Gerstein NS, Martin HB, Toma, G MD; Sibbitt RR, Sibbitt WL Jr.. Central venous access with the new safety technology the reciprocating procedure device. Journal Clinical Anesthesiology 2008 (In Press).

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00651625     History of Changes
Other Study ID Numbers: HRRC 04-347, HRRC 04-347, 04-347
Study First Received: March 21, 2008
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
arthrocentesis
injections
anesthesia
biopsy
aspiration
syringe
safety
pain

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoarthritis
Thyroid Nodule
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on September 18, 2014