Recruiting

Reletex Reliefband

Sponsor:

University of Pennsylvania

Code:

NCT07063979

Conditions

Postoperative Nausea and Vomiting

Bariatric Sleeve Gastrectomy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient

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 Details

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

Conditions

Postoperative Nausea and Vomiting

Bariatric Sleeve Gastrectomy

Study ID

NCT07063979

Start date

Nov 4, 2025

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Arm 1, will receive the placebo or sham device.

The sham device will mimic the actual device by looks, and feeling, but won't actually emit a low-level electric current to stimulate the nerves.

active comparator: Arm 2- will receive active band

This is the actual device, so it will emit a low-level electric current and stimulate the nerves of the patient.

Interventions

Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient

Use of a wearable device, which emits a low-level electric current across 2 small electrodes on the underside of the patient's wrist, stimulating the nerves and sending a signal to the center of the brain that can help suppress nausea/vomiting. A review of the medical literature found studies that found the device to be effective in reducing PONV. It has been studied in the past, but the trials had limitations, not double blinded and no true placebo. We have proposed a true double blind randomized study utilizing a placebo which specifically mimics the actual device as closely as possible to prevent bias and adversely effecting data results. Nor had this device been tested specifically in the postop bariatric surgical patient.

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.

The company who makes the active device created a sham wearable device that looks like the active, and buzzes (to give the feel of stimulation), but does not actual emit a low-leve electrical signal to stimulate the nerves.

Primary outcome measure

  • Post operative nausea and vomiting (PONV) incidents utilizing the PONV impact scale in placebo/sham vs active group. [ Time Frame: This will be assessed over the first 24 hours postoperatively. ]

Central Contacts and Locations

Central contacts

Donna L Post, Bariatric Coordinator/Nurse Navigator, BSN

609-423-8102donna.post@pennmedicine.upenn.edu

Lisa Dobruskin, MD Medical Director Penn Med Princeton Bariatrics, MD

609-785-5870yelizaveta.dobruskin@pennmedicine.upenn.edu

Locations

Princeton Hospital

Recruiting

Plainsboro, New Jersey, United States, 08536

Contacts

Donna Post

609-423-8102donna.post@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Prevention of Postoperative Nausea and Vomiting in Bariatric Patient
  • Reletex Reliefband to prevent PONV
  • Preventing PONV in Bariartic Postop patient
  • Reliefband

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-06-10.