We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00651625
Recruitment Status : Completed
First Posted : April 3, 2008
Results First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
University of New Mexico

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Trauma Thyroid Nodule Cancer Device: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001 Device: conventional syringe - BD Ref 309604 Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Reciprocating Procedure Device Versus the Conventional Syringe in Syringe-and-Needle Procedures
Study Start Date : November 2004
Actual Primary Completion Date : January 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1
The intervention is the use of the reciprocating procedure device (RPD) (AVANCA Re No. 1091001) (intervention) (Arm 1) with and without ultrasound guidance (intervention) in a syringe and needle procedure in comparison to a conventional syringe (BD Ref 309604) (control, Arm 2).
 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
The conventional syringe (BD Ref 309604) 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) and compared to 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.
Other Names:
  • syringe
  • conventional syringe
  • traditional syringe


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pain Using VAS (Visual Analogue Pain Scale) [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Aspirated Fluid Volume [ Time Frame: during procedure ]
    Aspirated fluid volume during procedure

  2. Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation) [ Time Frame: during procedure, 2 weeks afterwards, and 6 months afterwards ]
  3. Physician Satisfaction [ Time Frame: during procedure ]

    0- 10 cm visual analogue satisfaction scale (VASS)

    0-10 cm VASS at 2 weeks compared to 0-10 cm VASS pain scale at 0 weeks where 0= completely dissatisfied, and 10 = completely satsified. The difference (2 week VAS-0 week VAS) is the outcome measure



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 child or susceptible population
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651625


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Wilmer L Sibbitt, Jr., MD University of New Mexico
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:
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).

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

Layout table for additonal information
Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00651625    
Other Study ID Numbers: HRRC 04-347
HRRC 04-347 ( Other Grant/Funding Number: University of New Mexico )
04-347 ( Other Identifier: University of New Mexico )
First Posted: April 3, 2008    Key Record Dates
Results First Posted: March 2, 2016
Last Update Posted: March 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of New Mexico:
arthrocentesis
injections
anesthesia
biopsy
 aspiration
syringe
safety
pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Nodule
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases