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NCT07063979 · ClinicalTrials.gov registry record · NA
Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband, With Current ERAS (Enhanced Recovery After Surgery) Protocol to Further Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient Within the First 24 Hours Postoperatively.
A NA study of Postoperative Nausea and Vomiting and Bariatric Sleeve Gastrectomy, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT07063979: Recruiting NA study of Postoperative Nausea and Vomiting and Bariatric Sleeve Gastrectomy, sponsored by University of Pennsylvania.
NCT07063979 is a NA study of Postoperative Nausea and Vomiting and Bariatric Sleeve Gastrectomy that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 100 participants, below the 424-participant average among 10 other Postoperative Nausea and Vomiting trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07063979, a NA study of Postoperative Nausea and Vomiting and Bariatric Sleeve Gastrectomy, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn if the Reletex Reliefband device when used in conjunction with our current treatments will further decrease postoperative nausea and vomiting. The Investigators want to test how well it works, specifically in bariatric surgery patients that are at a higher risk for nausea and vomiting after surgery. Furthermore, the investigators would like to see if using this non-drug treatment option might allow for the same or better control of nausea and vomiting with fewer side effects than the current medications used. This may decrease drowsiness, and allow for earlier mobility, increase comfort, and generally accelerate recovery after surgery. The main questions it aims to answer are: * Does the use of Reletex Reliefband decrease postoperative nausea and vomiting (PONV) in the Bariatric surgical patient, therefore decreasing need for additional anti-emetics. * Does the use of Reletex Reliefband the use of the Reletex Reliefband during the immediate post-operative period reduce PONV, allowing for early mobility, decreased pain and length of stay (LOS). * Does the use of Reletex Reliefband decrease the use of medications for nausea and therefore decrease costs. * Does the use of Reletex Reliefband reduce prolonged PONV and therefore prevent the downstream effects, i.e. less mobility, increased pain, inhibit the patients' ability to comply with recommended treatments. * If reducing PONV using non-pharmaceutical approaches will improve outcomes and patient experiences. Researchers will compare to a placebo (a look-alike device) to see if the Reletex Reliefband works to decrease PONV. Participants will: * All receive the standard Enhanced Recovery After Surgery (ERAS) Protocol before, during and after surgery. (This includes use of premedications for pain, and nausea) * Have a band applied and turned on at the completion of the patient's bariatric sleeve surgery. The band will be adjusted based on need and worn for a total of 24 h
Primary Outcome
Evaluate the effectiveness of utilizing the Reletex Reliefband to decrease incidence of postoperative nausea and vomiting (PONV). This would be measured using the PONV impact scale and taking an average of this throughout the 24 hour period for all participants. Our end point goal would be that those with the active device would have an average PONV score of \<5 indicating minimal PONV.
Conditions Studied
Interventions
- DEVICE Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient
- DEVICE A sham device that will mimic the active wearable device. It will look the same, and buzz but will not actually admit a low-leve electric current that would stimulate the nerves.
Study Locations (1)
New Jersey
- Princeton Hospital - Plainsboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-11-04 |
| Est. Completion | 2026-07 |
| Phase | NA |
What NCT07063979 shows while recruiting
NCT07063979 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 424-participant average among 10 other Postoperative Nausea and Vomiting trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Postoperative Nausea and Vomiting appearing as the primary indexed condition, and to 2 interventions - of which Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient is the first listed.
NCT07063979 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT07063979 about?
NCT07063979 is a clinical study titled "Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband, With Current ERAS (Enhanced Recovery After Surgery) Protocol to Further Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient Within the First 24 Hours Postoperatively.". The goal of this clinical trial is to learn if the Reletex Reliefband device when used in conjunction with our current treatments will further decrease postoperative nausea and vomiting. The Investigators want to test how well it works, specifically in bariatric surgery patients that are at a higher...
What is the current status of trial NCT07063979?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-11-04. Estimated completion is 2026-07.
What conditions does trial NCT07063979 study?
This clinical trial studies the following conditions: Postoperative Nausea and Vomiting, Bariatric Sleeve Gastrectomy.
What interventions are being tested in trial NCT07063979?
The interventions under investigation include: Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient (DEVICE), A sham device that will mimic the active wearable device. It will look the same, and buzz but will not actually admit a low-leve electric current that would stimulate the nerves. (DEVICE).
Who is sponsoring clinical trial NCT07063979?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07063979 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07063979's enrollment target sits among peer trials
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Source ClinicalTrials.gov registry export · 2026-08-08
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