Reletex Reliefband for Postoperative Nausea and Vomiting

Overseen By Donna L Post, Bariatric Coordinator/Nurse Navigator, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Gastroparesis, Pregnancy, Cardiac devices, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Reletex Reliefband, a wearable device, can reduce nausea and vomiting after weight-loss surgery (bariatric surgery). The device uses gentle electrical stimulation (transcutaneous electrical nerve stimulation) to potentially ease these symptoms, aiming for better recovery with fewer side effects than current medications. Researchers will test the device against a placebo to determine its effectiveness. Ideal participants are adults with a BMI of 35 or higher who are scheduled for robotic sleeve gastrectomy. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgery recovery options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, all participants will receive standard treatments for pain and nausea as part of the study.

What prior data suggests that the Reletex Reliefband device is safe for bariatric surgery patients?

Studies have shown that the Reletex Reliefband is safe to use. The FDA has already approved this device for treating nausea and vomiting caused by motion sickness, chemotherapy, and morning sickness. This approval indicates that the device is generally well-tolerated. Some users might experience mild skin irritation where the band contacts the skin, but serious side effects are rare. Because it doesn't use drugs, it avoids common medication side effects like drowsiness. This makes it a promising choice for those seeking to manage nausea without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Reletex Reliefband is unique because it uses transcutaneous electrical nerve stimulation (TENS) to tackle postoperative nausea and vomiting. Unlike traditional medications that might involve drugs and potential side effects, this wearable device delivers a low-level electric current to stimulate nerves directly. Researchers are excited about this treatment because it offers a non-invasive, drug-free option that could provide quick relief and reduce reliance on medication.

What evidence suggests that the Reletex Reliefband is effective for reducing postoperative nausea and vomiting?

Research has shown that the Reletex Reliefband, which participants in this trial may receive, might help reduce nausea and vomiting after surgery, especially for patients undergoing weight-loss surgery. A study by Lee and Fan in 2009 found that similar devices, which stimulate a specific point on the wrist, effectively prevent these symptoms. The device sends small electrical pulses to nerves, potentially controlling nausea. Although more research is needed, early results are promising for reducing nausea without medication side effects, such as drowsiness, and may lead to quicker recovery for patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Lisa Dobruskin, MD

Principal Investigator

Penn Medicine Princeton Medical Center for Bariatric Surgery and Metabolic Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with a BMI of 35 or higher, undergoing Robotic Sleeve Gastrectomy. Participants must be able to understand and follow long-term post-surgery requirements and consent on their own behalf.

Inclusion Criteria

BMI 35 or greater

I am between 18 and 75 years old.

I am eligible for and will have a robotic sleeve gastrectomy.

Exclusion Criteria

Pregnancy

Presence of a cardiac pacemaker/defibrillator or intrathecal pump

Current smoker or tobacco use within 30 days of procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application and titration of the Reletex Reliefband device to manage postoperative nausea and vomiting

24 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wearable Transcutaneous electrical Nerve Stimulation unit

Trial Overview The study tests if the Reletex Reliefband, a wearable nerve stimulation device, can reduce nausea and vomiting after bariatric surgery better than standard treatments alone. It's compared to a sham device that looks identical but doesn't emit an electric current.

How Is the Trial Designed?

Group I: Arm 2- will receive active band Active Control 1 Intervention

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

Group II: Arm 1, will receive the placebo or sham device. Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07063979

Study Details | NCT07063979 | Use of Transcutaneous ... Does the use of Reletex Reliefband reduce prolonged PONV and therefore prevent the downstream effects, i.e. less mobility, increased pain, ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/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

Use of Transcutaneous Electrical Nerve Stimulation Device ... Does the use of Reletex Reliefband decrease postoperative nausea and vomiting (PONV) in the Bariatric surgical patient, therefore decreasing ...

3. aapc.com aapc.com/codes/webroot/upload/general_pages_docs/document/TENS_Tx_Nausea_Vomiting.pdf?srsltid=AfmBOorYzaHe-uCVVklh8ABHgspWQZxbqcMafNUpC8FSBTuHXHdCKGmD

Transcutaneous Electrical Nerve Stimulation (TENS) for the ... Lee and Fan (2009) evaluated the efficacy and safety of P6 acupoint stimulation in preventing postoperative nausea and vomiting (PONV) in a systematic review.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39748403/

a study protocol for a multicenter randomized controlled trial This multi-center randomized controlled trial aims to reveal the therapeutic effect of the wearable TEAS bracelet on PONV.

5. mcgs.bcbsfl.com mcgs.bcbsfl.com/MCG?mcgId=02-61000-04&pv=false

Subject: Transcutaneous Electric Nerve Stimulation (TENS) Data in published medical literature are inadequate to permit scientific conclusions on long-term and net health outcomes. Combination or ...

6. reliefband.com reliefband.com/?srsltid=AfmBOorN89i5XHsDneivCv-A7upui8tquTgwJuDp-xahR0VPT2WeM0Pz

Reliefband® Reliefband is a safe, effective and drug-free alternative to reduce nausea without side effects. Fast acting and long lasting.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K191547.pdf

August 30, 2019 ReliefBand Technologies LLC Barbara ... ReliefBand 2.0 is indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, chemotherapy and morning sickness ...

8. aapc.com aapc.com/codes/webroot/upload/general_pages_docs/document/TENS_Tx_Nausea_Vomiting.pdf?srsltid=AfmBOorE4a6uLCWo-qbY7OaVcoprI0OnKY33fEjHDaxHN9iT_8M1XmRA

Transcutaneous Electrical Nerve Stimulation (TENS) for the ... It is intended for treatment of nausea and vomiting due to pregnancy. Reletex® is being marketed for postoperative nausea and vomiting. Acupressure wristbands ( ...