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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02749071
Other study ID # CS-100
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date October 2019

Study information

Verified date October 2019
Source EndoStim Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The purpose of this investigation is to demonstrate the safety and effectiveness of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System in the treatment of subjects with gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled clinical investigation. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for a 6-month, double-blind phase followed by an additional open-label treatment phase in which all subjects will receive electrical stimulation therapy for a total of 12 months. Subjects continue on stimulation treatment and an extended open-label follow-up phase includes an 18 month post-stimulation phone interview followed by annual visits through 5 years post-stimulation.


Recruitment information / eligibility

Status Terminated
Enrollment 161
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 22 Years to 75 Years
Eligibility Inclusion Criteria:

1. Able and willing to provide written informed consent

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:

1. Previous EndoStim LES System implant and/or implant attempt

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

Study Design


Intervention

Procedure:
Laparoscopic implantation surgery
Laparoscopic surgery to implant the pulse generator and bipolar lead.
Device:
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)

Locations

Country Name City State
Belgium Universitaire Ziekenhuizen Leuven Leuven
Netherlands Clinical Trial Center Maastricht Maastricht
United Kingdom University College London London
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 Institute of Esophageal and Reflux Surgery Englewood Colorado
United States University of Southern California (USC) Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee
United States Columbia University Medical Center New York New York
United States Cornell University Weill Medical College New York New York
United States St. Joseph's Hospital and Medical Center Phoenix Arizona
United States Allegheny Health Network Research Institute Pittsburgh Pennsylvania
United States Oregon Clinic Portland Oregon
United States Oregon Health Science University Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States Baylor Scott & White Research Institute Round Rock Texas
United States HonorHealth Research Institute Scottsdale Arizona
United States Stanford Center for Clinical Research Stanford California
United States University of South Florida Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
EndoStim Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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