An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
Public ClinicalTrials.gov record NCT02749071. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Gastroesophageal Reflux Disease (GERD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.
Study identification
- NCT ID
- NCT02749071
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 161 participants
Conditions and interventions
Conditions
Interventions
- Laparoscopic implantation surgery with or without crural repair Procedure
- EndoStim stimulation for first six months of study Device
- EndoStim stimulation from Month 6 thru end of study Device
- Sham EndoStim stimulation for first six months of study Device
Procedure · Device
Eligibility (public fields only)
- Age range
- 22 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2016
- Primary completion
- Sep 30, 2019
- Completion
- Sep 30, 2019
- Last update posted
- Jul 21, 2026
2016 – 2019
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| University of Southern California (USC) | Los Angeles | California | 90033 | — |
| Stanford Center for Clinical Research | Stanford | California | 94305 | — |
| Institute of Esophageal and Reflux Surgery | Englewood | Colorado | 80113 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Cornell University Weill Medical College | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Carolinas HealthCare System | Charlotte | North Carolina | 28260 | — |
| The MetroHealth System | Cleveland | Ohio | 44109 | — |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Oregon Clinic | Portland | Oregon | 97213 | — |
| Oregon Health Science University | Portland | Oregon | 97239 | — |
| Allegheny Health Network Research Institute | Pittsburgh | Pennsylvania | 15224 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Baylor Scott & White Research Institute | Round Rock | Texas | 78665 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02749071, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2026 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02749071 live on ClinicalTrials.gov.