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NCT01510379 · ClinicalTrials.gov registry record · NA
Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
A NA study of Nausea and Vomiting Post-foregut Surgery, sponsored by Kyle A Perry.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01510379: Completed NA study of Nausea and Vomiting Post-foregut Surgery, sponsored by Kyle A Perry.
NCT01510379 is a NA study of Nausea and Vomiting Post-foregut Surgery that has completed, run by Kyle A Perry. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01510379, a NA study of Nausea and Vomiting Post-foregut Surgery, has completed, sponsored by Kyle A Perry.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).
Conditions Studied
Interventions
- DEVICE Reletex
- DRUG 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
Study Locations (1)
Ohio
- The Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-08 |
| Phase | NA |
What the finished NCT01510379 record still lists
NCT01510379 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Nausea and Vomiting Post-foregut Surgery appearing as the primary indexed condition, and to 4 interventions - of which Reletex is the first listed.
NCT01510379 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01510379 about?
NCT01510379 is a clinical study titled "Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery". 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...
What is the current status of trial NCT01510379?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2011-08. Estimated completion is 2012-08.
What conditions does trial NCT01510379 study?
This clinical trial studies the following conditions: Nausea and Vomiting Post-foregut Surgery.
What interventions are being tested in trial NCT01510379?
The interventions under investigation include: Reletex (DEVICE), 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).
Who is sponsoring clinical trial NCT01510379?
This trial is sponsored by Kyle A Perry, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01510379 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01510379's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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