Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01510379
The ClinicalTrials.gov registry entry for NCT01510379 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyle A Perry, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.