NCT07063979 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.
| NCT ID | NCT07063979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Postoperative Nausea and Vomiting |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-11-04 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 hours postoperatively. * Have a pedometer clipped to their gown, to remain in place for 24 hours postoperatively * Be assessed regularly during their hospital stay by the nurses to monitor the site of the band, their level of nausea/vomiting, pain levels, and level of mobility
Eligibility Criteria
Inclusion Criteria: * Adults 18-75 years of age * BMI 35 or greater * Patients eligible for and undergoing a Robotic Sleeve Gastrectomy * Able to consent on own behalf Exclusion Criteria: * A diagnosis of gastroparesis * Pregnancy * Presence of a cardiac pacemaker/defibrillator or intrathecal pump * Current smoker or tobacco use within 30 days of procedure. * Known allergic reactions to conductivity gel. Due to the nature of the Robotic Sleeve Gastrectomy patients who may be unable to follow or comprehend the long-term restrictions and/or requirements inherent of the surgery due to altered mentation are excluded from having the surgery.
Contact & Investigator
Donna L Post, Bariatric Coordinator/Nurse Navigator, BSN
✉ donna.post@pennmedicine.upenn.edu📞 609-423-8102
Lisa Dobruskin, MD
PRINCIPAL INVESTIGATOR
Penn Medicine Princeton Medical Center for Bariatric Surgery and Metabolic Medicine
Frequently Asked Questions
Who can join the NCT07063979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postoperative Nausea and Vomiting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07063979 currently recruiting?
Yes, NCT07063979 is actively recruiting participants. Contact the research team at donna.post@pennmedicine.upenn.edu for enrollment information.
Where is the NCT07063979 trial being conducted?
This trial is being conducted at Plainsboro, United States.
Who is sponsoring the NCT07063979 clinical trial?
NCT07063979 is sponsored by University of Pennsylvania. The principal investigator is Lisa Dobruskin, MD at Penn Medicine Princeton Medical Center for Bariatric Surgery and Metabolic Medicine. The trial plans to enroll 100 participants.