Reletex Reliefband plus ERAS to reduce nausea after robotic sleeve gastrectomy
Official title: Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband to Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient
Run by University of Pennsylvania · NCT07063979 · Data updated 2026-11-12
This trial will test whether wearing the Reletex Reliefband in addition to standard ERAS care can reduce nausea and vomiting in adults having robotic sleeve gastrectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Plainsboro, New Jersey) |
| Status | Recruiting |
| Started | November 4, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07063979 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 years old with BMI ≥35 who are eligible for and scheduled to undergo a robotic sleeve gastrectomy and can provide informed consent are the intended participants.
✕Probably not a fit
Patients with gastroparesis, pregnancy, cardiac pacemakers/defibrillators or intrathecal pumps, recent tobacco use, or known allergy to conductivity gel (and those not undergoing robotic sleeve gastrectomy) are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for robotic sleeve gastrectomy at a single center will be assigned to wear either an active Reletex Reliefband or a visually identical sham device starting at the end of surgery. The band is turned on in the PACU at a low setting and settings are titrated using the Post Operative Nausea and Vomiting (PONV) Impact Scale with repeated checks in PACU and on the surgical floor; device battery limitations require removal and replacement per protocol around 12 hours. The study compares rates of PONV and need for additional antiemetics within the first 24 postoperative hours to see if the non-drug device improves comfort, mobility, and recovery when added to current care.
Why it matters
Potential benefit: If successful, this could reduce postoperative nausea and vomiting, lower the need for antiemetic drugs and their side effects, and help patients mobilize and recover sooner.
How similar studies have gone: Prior small studies of wrist nerve-stimulation or acupressure-like devices for PONV have shown mixed but sometimes promising reductions in nausea, though evidence specific to bariatric sleeve patients is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Princeton Hospital
Plainsboro, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Lisa Dobruskin, MD — Penn Medicine Princeton Medical Center for Bariatric Surgery and Metabolic Medicine
- Study coordinator: Donna L Post, Bariatric Coordinator/Nurse Navigator, BSN
- Email: donna.post@pennmedicine.upenn.edu
- Phone: 609-423-8102
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.