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 | Recruiting FDA Device

• 1 other identifier: 858175
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Post operative nausea and vomiting (PONV) incidents utilizing the PONV impact scale in placebo/sham vs active group.

  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.

  This will be assessed over the first 24 hours postoperatively.

Secondary Outcomes (1)

• Participants w/active wearable device to prevent PONV will have a reduced need for additional anti-emetics. This will be measured by looking at the average number of anti-emetics given as needed for the first 24 hours in both arms.

  24 hours postoperatively

Study Arms (2)

Arm 1, will receive the placebo or sham device.

SHAM COMPARATOR

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.

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.

Arm 2- will receive active band

ACTIVE COMPARATOR

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

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

Interventions

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

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.

Arm 2- will receive active band

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

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.

Arm 1, will receive the placebo or sham device.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Princeton Hospital

Plainsboro, New Jersey, 08536, United States

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Lisa Dobruskin, MD

  Penn Medicine Princeton Medical Center for Bariatric Surgery and Metabolic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna L Post, Bariatric Coordinator/Nurse Navigator, BSN

CONTACT

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

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The double-blind randomization of the devices, actual or sham/placebo will be controlled by the device manufacturer, so the clinicians involved in direct patient care will not be biased, and the documentation/data collection will remain unbiased
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director Bariatric Surgery & Metabolic Medicine

Model Details: Single institution study. This will be a double-blind randomized study with utilization of an active device and a placebo device. With Arm 1- Placebo N= 50 participants and Arm 2- Active N=50 participants

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within one year of conclusion of the study
• Access Criteria: supplementary material included with publication

Locations

US (1)