Study Stopped
Company no longer operational
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
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)
1 other identifier
interventional
161
4 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 18, 2019
October 1, 2019
3.4 years
April 15, 2016
October 16, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of device and/or procedure-related serious adverse events
Rate of occurrence of device and/or procedure-related serious adverse events after 12 months
12 months
Percentage of subjects achieving pH success (pH<4 for mo more than 5.3% of time or at least 50% improvement in pH compared to baseline)
Comparison between treatment and control group: percentage of subjects achieving pH success ((pH\<4 for mo more than 5.3% of time or at least 50% improvement in pH compared to baseline)
Comparison of 6 months to baseline data
Study Arms (2)
Control Group
SHAM COMPARATORThis group will undergo laparoscopic implantation surgery. The device will not be activated: Sham EndoStim stimulation for first six months of study. It will be activated at the Month 6 visit and provide lower esophageal stimulation from Month 6 thru end of study.
Treatment Group
EXPERIMENTALThe group will undergo laparoscopic implantation surgery. The device will be activated two weeks post-implantation and the subject will receive EndoStim stimulation for first six months of study and continue with EndoStim stimulation from Month 6 thru end of study.
Interventions
Laparoscopic surgery to implant the pulse generator and bipolar lead.
Lower esophageal stimulation
Lower esophageal stimulation
EndoStim device remains "off" (no stimulation delivered)
Eligibility Criteria
You may qualify if:
- Able and willing to provide written informed consent
- Able and willing to comply with required study procedures and follow-up schedule
- years of age at the time of informed consent
- Documented symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation and/or heartburn which is defined as burning epigastric or substernal pain which responds to acid neutralization or suppression) which requires daily use of proton pump inhibitors (PPIs) or other anti-reflux drug therapy, who continue to have symptoms despite maximum medical therapy or are "intolerant" -severe side-effects (e.g. anaphylaxis or severe allergic reaction, recurrent C. difficile, severe hypomagnesaemia) to one PPI or mild/moderate side effect (e.g. nausea, vomiting, diarrhea or abdominal pain) to at least 2 PPIs of different chemical classes.
- Symptomatic improvement on PPI therapy demonstrated by a composite GERD-health-related quality of life (HRQL) score of ≥20 off PPI, and a ≥10 point improvement on PPI compared to the off PPI composite GERD-HRQL score. Patients who meet the definition above of PPI intolerant are not required to have ≥10 point improvement. The on-PPI score to satisfy this criterion will be the score from the GERD-HRQL assessment completed after resuming PPIs following the Baseline visit.
- Esophagitis ≤ Grade B (Los Angeles (LA) classification) as measured by upper endoscopy off PPI and H2 blockers for 10-14 days
- Esophageal body contraction amplitude \> 30 mmHg for \> 30% of swallows and \> 30% peristaltic contractions on HRM or ≥ 30% peristaltic contractions with DCI \>450.
- Suitable surgical candidate able to undergo general anesthesia and laparoscopic surgery
You may not qualify if:
- Previous EndoStim LES System implant and/or implant attempt
- Previous surgery involving the gastroesophageal junction or the lead implant site, such as a Nissen fundoplication
- Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
- Hiatal hernia larger than 3 cm as determined by endoscopy
- History of gastroparesis
- Any non-GERD esophageal motility disorders that in the opinion of investigator precludes an anti-reflux procedure
- History of or known esophageal stricture or significant esophageal anatomic abnormalities (obstructive lesions, etc.)
- Barrett's esophagus or any grade of dysplasia
- Documented history of esophagitis Grade C or D (LA Classification)
- History of suspected or confirmed esophageal or gastric cancer
- Esophageal or gastric varices
- Symptoms of dysphagia more than once per week every week within the last 3 months
- Unable to tolerate withdrawal from H2 Blockers or PPI medications
- Suspected or known allergies to titanium, platinum, iridium, stainless steel, silicone, epoxy, or nylon
- Body mass index (BMI) \> 35 kg/m2
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EndoStim Inc.lead
Study Sites (21)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
University of Southern California (USC)
Los Angeles, California, 90033, United States
Stanford Center for Clinical Research
Stanford, California, 94305, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, 80113, United States
University of South Florida
Tampa, Florida, 33606, United States
Cornell University Weill Medical College
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolinas HealthCare System
Charlotte, North Carolina, 28260, United States
The MetroHealth System
Cleveland, Ohio, 44109, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oregon Clinic
Portland, Oregon, 97213, United States
Oregon Health Science University
Portland, Oregon, 97239, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Baylor Scott & White Research Institute
Round Rock, Texas, 78665, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Clinical Trial Center Maastricht
Maastricht, Netherlands
University College London
London, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas J Shaheen, MD, MPH
University of North Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2016
First Posted
April 22, 2016
Study Start
May 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
October 18, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share