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NCT03555266 · ClinicalTrials.gov registry record · NA
NSS-2 BRIDGE Device in Post-Operative Pain Management
A NA study of Surgery and Acute Pain, sponsored by Jacques E. Chelly.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT03555266 is a NA study of Surgery and Acute Pain that has completed, run by Jacques E. Chelly. The registered enrollment target is 65 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03555266, a NA study of Surgery and Acute Pain, has completed, sponsored by Jacques E. Chelly.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. Therefore, in order to combat this growing health crisis at the ground level, it is incumbent upon the medical community to explore alternative methods of pain control to treat the surgical population in order to reduce the incidence of post-operative opioid addiction. Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing research has shown to be effective as a complementary method of pain management. While PNFS is not a novel concept, clinical indications of auricular field stimulation have been limited in the past due to requirement of bulky, stationary and non-disposable stimulators and electrodes. These technological limitations made it difficult to establish the real clinical potential of auricular stimulation for the perioperative management of pain in surgical patients, despite the demonstration that auriculotherapy has been shown to relieve pain in the postoperative setting. The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. These symptoms include abdominal pain, anxiety and post-operative nausea and vomiting; conditions which are also present following major oncologic abdominal surger
Conditions Studied
Interventions
- DEVICE Sham NSS-2 BRIDGE
- DEVICE NSS-2 Bridge
Study Locations (1)
Pennsylvania
- UPMC Shadyside Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-10-23 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03555266
The ClinicalTrials.gov registry entry for NCT03555266 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The listed sponsor is Jacques E. Chelly, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Sham NSS-2 BRIDGE is the first listed.
NCT03555266 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03555266 about?
NCT03555266 is a clinical study titled "NSS-2 BRIDGE Device in Post-Operative Pain Management". The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depre...
What is the current status of trial NCT03555266?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2018-10-23. Estimated completion is 2021-06-30.
What conditions does trial NCT03555266 study?
This clinical trial studies the following conditions: Surgery, Acute Pain, Abdominal Cancer.
What interventions are being tested in trial NCT03555266?
The interventions under investigation include: Sham NSS-2 BRIDGE (DEVICE), NSS-2 Bridge (DEVICE).
Who is sponsoring clinical trial NCT03555266?
This trial is sponsored by Jacques E. Chelly, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03555266 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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