NCT07063979 · University of Pennsylvania
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.
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
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.
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 measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Plainsboro, New Jersey
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations