---
title: Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
nct_id: NCT01510379
overall_status: COMPLETED
phase: NA
sponsor: Kyle A Perry
study_type: INTERVENTIONAL
primary_condition: Nausea and Vomiting Post-foregut Surgery
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01510379.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01510379"
ct_last_update_post_date: 2014-03-05
last_seen_at: "2026-05-12T06:59:04.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery

**Official Title:** Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial

**NCT ID:** [NCT01510379](https://clinicaltrials.gov/study/NCT01510379)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Kyle A Perry
- **Conditions:** Nausea and Vomiting Post-foregut Surgery
- **Start Date:** 2011-08
- **Completion Date:** 2012-08
- **CT.gov Last Update:** 2014-03-05

## Brief Summary

The effect a ReletexTM device has on postoperative nausea and vomiting when used with ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to decrease nausea and vomiting. The investigators will randomize 100 patients who are having a fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or Heller Myotomy for achalasia into two groups. A control group will receive scheduled ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days. These patients will also get scheduled ondansetron and phenergan as needed, like the control group. The investigators will compare nausea, retching, and the amount of supplemental nausea medication used between the two groups. The patients will be provided a diary to document their nausea, retching, and medication use.

The hypothesis of this study is that use of the ReletexTM device will reduce post-operative nausea and vomiting, and will reduce post-operative use of anti-emetic medications in patients who have undergone foregut surgery.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age 18-85
* Planned fundoplication
* Willingness to comply with randomization and follow-up protocol
* English speaking

Exclusion Criteria:

* \< 18 years of age or \> 85
* Chronic nausea requiring medical treatment
* Planned concomitant procedures
* Pacemaker or automatic internal cardiac defibrillator
```

## Arms

- **Reletex** (ACTIVE_COMPARATOR) — Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
- **Control** (OTHER) — Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.

## Interventions

- **Reletex** (DEVICE) — Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.
- **IV ondansetron 4 mg q 6 hours for a total of 4 doses** (DRUG)
- **IV promethazine 25 mg q 6 hours prn** (DRUG)
- **Elixir promethazine 25 mg q 6 hours prn after discharge** (DRUG)

## Primary Outcomes

- **Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.** _(time frame: 24 hours)_ — Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).

## Secondary Outcomes

- **Quantify the Amounts of Phenergan Used Between the Two Groups.** _(time frame: one week)_

## Locations (1)

- The Ohio State University Medical Center, Columbus, Ohio, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the ohio state university medical center|columbus|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01510379.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01510379*  
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