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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.
NCT07063979 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07063979
The ClinicalTrials.gov registry entry for NCT07063979 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07063979 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07063979?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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