Clinical trial · Interventional
Reciprocating Medical Devices - a Study of a New Safety Device
Randomized Controlled Trial of the Reciprocating Procedure Device Versus the Conventional Syringe in Syringe-and-Needle Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Osteoarthritis | — | UNRESOLVED | — |
| Rheumatoid Arthritis | — | UNRESOLVED | — |
| Thyroid Nodule | — | UNRESOLVED | — |
| Trauma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional syringe - BD Ref 309604 | Device | — | UNRESOLVED |
| Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 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).
- interventionNames
- Device: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- 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.
- interventionNames
- Device: conventional syringe - BD Ref 309604
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (24)
- BACKGROUNDSibbitt 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. PMID 18796180
- BACKGROUNDSibbitt 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. No abstract available. PMID 18656735
- BACKGROUNDSibbitt 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. PMID 18583303
- BACKGROUNDMoorjani 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. PMID 18576358
- BACKGROUNDSibbitt 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. PMID 18568356
- BACKGROUNDMoorjani 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. PMID 18412301
- BACKGROUNDSibbitt 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. doi: 10.1097/01.RVI.0000236837.47302.8E.