An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
NCT ID: NCT02749071
Last Updated: 2019-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
161 participants
INTERVENTIONAL
2016-05-31
2019-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (GERD)
NCT02514616
Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
NCT01574339
EndoStim Patient Registry
NCT02441400
Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease
NCT01578642
[Impedance Measurement for Non-Erosive Reflux Disease
NCT02997527
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group
This 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.
Laparoscopic implantation surgery
Laparoscopic surgery to implant the pulse generator and bipolar lead.
EndoStim stimulation from Month 6 thru end of study
Lower esophageal stimulation
Sham EndoStim stimulation for first six months of study
EndoStim device remains "off" (no stimulation delivered)
Treatment Group
The 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.
Laparoscopic implantation surgery
Laparoscopic surgery to implant the pulse generator and bipolar lead.
EndoStim stimulation for first six months of study
Lower esophageal stimulation
EndoStim stimulation from Month 6 thru end of study
Lower esophageal stimulation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laparoscopic implantation surgery
Laparoscopic surgery to implant the pulse generator and bipolar lead.
EndoStim stimulation for first six months of study
Lower esophageal stimulation
EndoStim stimulation from Month 6 thru end of study
Lower esophageal stimulation
Sham EndoStim stimulation for first six months of study
EndoStim device remains "off" (no stimulation delivered)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Able and willing to comply with required study procedures and follow-up schedule
3. 22 - 75 years of age at the time of informed consent
4. 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.
5. 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.
6. Excessive lower esophageal acid exposure during pH monitoring (defined as distal esophageal pH \< 4 for \> 6.0% of the monitoring time) performed after at least 5 days off of PPIs and at least 2 days off of H2 blockers. At least 18 hour of esophageal pH recording will be considered adequate and inclusion will be based on the day (at least 18 hours of valid data) with the highest acid exposure percentage time.
7. Esophagitis ≤ Grade B (Los Angeles (LA) classification) as measured by upper endoscopy off PPI and H2 blockers for 10-14 days
8. Esophageal body contraction amplitude \> 30 mmHg for \> 30% of swallows and \> 30% peristaltic contractions on HRM or ≥ 30% peristaltic contractions with DCI \>450.
9. Suitable surgical candidate able to undergo general anesthesia and laparoscopic surgery
Exclusion Criteria
2. Previous surgery involving the gastroesophageal junction or the lead implant site, such as a Nissen fundoplication
3. Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
4. Hiatal hernia larger than 3 cm as determined by endoscopy
5. History of gastroparesis
6. Any non-GERD esophageal motility disorders that in the opinion of investigator precludes an anti-reflux procedure
7. History of or known esophageal stricture or significant esophageal anatomic abnormalities (obstructive lesions, etc.)
8. Barrett's esophagus or any grade of dysplasia
9. Documented history of esophagitis Grade C or D (LA Classification)
10. History of suspected or confirmed esophageal or gastric cancer
11. Esophageal or gastric varices
12. Symptoms of dysphagia more than once per week every week within the last 3 months
13. Unable to tolerate withdrawal from H2 Blockers or PPI medications
14. Suspected or known allergies to titanium, platinum, iridium, stainless steel, silicone, epoxy, or nylon
15. Body mass index (BMI) \> 35 kg/m2
16. Any significant multisystem diseases
17. Autoimmune or a connective tissue disorder (scleroderma, dermatomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST), Sjogren's Syndrome, Sharp's Syndrome, etc.) requiring therapy in the preceding 2 years
18. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c \> 9.5 in the previous 6 months or at screening/baseline
19. Significant cardiac arrhythmia or ectopy or significant cardiovascular disease (i.e. unstable angina pectoris, hemodynamically significant valvular disease, severe congestive heart failure), or any cardiac therapeutic intervention within the last 6 months.
20. Significant cerebrovascular event within the last 6 months
21. Existing implanted electrical stimulator (pacemaker, implantable cardioverter defibrillator, deep brain stimulator (DBS), bone growth or pelvic floor stimulators, drug pumps, etc.)
22. Female subject of child-bearing potential and is pregnant or nursing, or intends to become pregnant during the trial period, who is not using a reliable form of birth control
23. Currently enrolled in other potentially confounding research
24. Active infection as determined by the investigator
25. History of any malignancy, other than basal cell carcinoma, in the last 2 years
26. Life expectancy less than 3 years aa. Diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.) bb. Any condition that, at the discretion of the investigator or sponsor, would interfere with accurate interpretation of the study endpoints or preclude participation in the trial
22 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EndoStim Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicholas J Shaheen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
University of Southern California (USC)
Los Angeles, California, United States
Stanford Center for Clinical Research
Stanford, California, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, United States
University of South Florida
Tampa, Florida, United States
Cornell University Weill Medical College
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Carolinas HealthCare System
Charlotte, North Carolina, United States
The MetroHealth System
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Oregon Clinic
Portland, Oregon, United States
Oregon Health Science University
Portland, Oregon, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Scott & White Research Institute
Round Rock, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Clinical Trial Center Maastricht
Maastricht, , Netherlands
University College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Study website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CS-100
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.