Cancer Clinical Trial
— RPDOfficial title:
Randomized Controlled Trial of the Reciprocating Procedure Device Versus the Conventional Syringe in Syringe-and-Needle Procedures
Verified date | February 2016 |
Source | University of New Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 437 |
Est. completion date | August 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico |
United States,
Bankhurst AD, Nunez SE, Draeger HT, Kettwich SC, Kettwich LG, Sibbitt WL Jr. A randomized controlled trial of the reciprocating procedure device for intraarticular injection of corticosteroid. J Rheumatol. 2007 Jan;34(1):187-92. — View Citation
Draeger HT, Twining JM, Johnson CR, Kettwich SC, Kettwich LG, Bankhurst AD. A randomised controlled trial of the reciprocating syringe in arthrocentesis. Ann Rheum Dis. 2006 Aug;65(8):1084-7. Epub 2005 Dec 8. — View Citation
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).
Michael AA, Moorjani GR, Peisajovich A, Park KS, Sibbitt WL Jr, Bankhurst AD. Syringe size: does it matter in physician-performed procedures? J Clin Rheumatol. 2009 Mar;15(2):56-60. doi: 10.1097/RHU.0b013e31819c1fc4. — View Citation
Moorjani GR, Bedrick EJ, Michael AA, Peisajovich A, Sibbitt WL Jr, Bankhurst AD. Integration of safety technologies into rheumatology and orthopedics practices: a randomized, controlled trial. Arthritis Rheum. 2008 Jul;58(7):1907-14. doi: 10.1002/art.23499. — View Citation
Moorjani GR, Michael AA, Peisajovich A, Park KS, Sibbitt WL Jr, Bankhurst AD. Patient pain and tissue trauma during syringe procedures: a randomized controlled trial. J Rheumatol. 2008 Jun;35(6):1124-9. Epub 2008 Apr 15. — View Citation
Nunez SE, Bedrick EJ, Kettwich SC, Kettwich LG, Bankhurst AD, Sibbitt WL Jr. A randomized, controlled trial of the reciprocating procedure device for local anesthesia. J Emerg Med. 2008 Aug;35(2):119-25. doi: 10.1016/j.jemermed.2007.08.060. Epub 2008 Feb — View Citation
Nunez SE, Draeger HT, Rivero DP, Kettwich LG, Sibbitt WL Jr, Bankhurst AD. Reduced pain of intraarticular hyaluronate injection with the reciprocating procedure device. J Clin Rheumatol. 2007 Feb;13(1):16-9. — View Citation
Park KS, Peisajovich A, Michael AA, Sibbitt WL Jr, Bankhurst AD. Should local anesthesia be used for arthrocentesis and joint injections? Rheumatol Int. 2009 Apr;29(6):721-3. doi: 10.1007/s00296-008-0785-3. Epub 2008 Nov 27. — View Citation
Sander O. Intra-articular corticosteroid injections with the reciprocating procedure device reduced procedural pain and duration more than the conventional syringe. Evid Based Med. 2007 Aug;12(4):106. — View Citation
Sibbitt RR, Palmer DJ, Bankhurst AD, Sibbitt WL Jr. Integration of new safety technologies for needle aspiration of breast cysts. Arch Gynecol Obstet. 2009 Mar;279(3):285-92. doi: 10.1007/s00404-008-0710-8. Epub 2008 Jun 21. — View Citation
Sibbitt RR, Palmer DJ, Sibbitt WL Jr. Integration of patient safety technologies into sclerotherapy for varicose veins. Vasc Endovascular Surg. 2008 Oct-Nov;42(5):446-55. doi: 10.1177/1538574408318479. Epub 2008 Jun 25. — View Citation
Sibbitt RR, Palmer DJ, Sibbitt WL Jr. Reciprocating procedure device for thyroid cyst aspiration and ablative sclerotherapy. J Laryngol Otol. 2009 Mar;123(3):343-5. doi: 10.1017/S0022215108003551. Epub 2008 Sep 17. — View Citation
Sibbitt RR, Sibbitt WL Jr, Nunez SE, Kettwich LG, Kettwich SC, Bankhurst AD. Control and performance characteristics of eight different suction biopsy devices. J Vasc Interv Radiol. 2006 Oct;17(10):1657-69. — View Citation
Sibbitt RR, Sibbitt WL Jr, Palmer DJ, Bankhurst AD. Needle aspiration of peritonsillar abscess with the new safety technology: the reciprocating procedure device. Otolaryngol Head Neck Surg. 2008 Aug;139(2):307-9. doi: 10.1016/j.otohns.2008.04.003. — View Citation
Sibbitt W Jr, Sibbitt RR, Michael AA, Fu DI, Draeger HT, Twining JM, Bankhurst AD. Physician control of needle and syringe during aspiration-injection procedures with the new reciprocating syringe. J Rheumatol. 2006 Apr;33(4):771-8. Epub 2006 Mar 1. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Using VAS (Visual Analogue Pain Scale) | 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. | 2 weeks | No |
Secondary | Aspirated Fluid Volume | Aspirated fluid volume during procedure | during procedure | No |
Secondary | Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation) | during procedure, 2 weeks afterwards, and 6 months afterwards | Yes | |
Secondary | Physician Satisfaction | 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 |
during procedure | No |
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