Clinical Trial Details

Overview

Research Study Summary

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)

Purpose
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.
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CW ID: 222921
Date Last Changed: February 3, 2017

Clinical Trial Snapshot

Gender
Both Male and Female
Age
22 and up
Overall Status
Recruiting
Lead Sponsor
EndoStim Inc.
Facility Type
N/A

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 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.
  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.
  7. Esophagitis = Grade B (Los Angeles (LA) classification) as measured by upper endoscopy off PPI for 10-14 days
  8. Resting LES end expiratory pressure = 5mm Hg as measured by high resolution manometry (HRM) performed within 6 months of enrollment
  9. Esophageal body contraction amplitude > 30 mmHg for > 30% of swallows and > 30% peristaltic contractions on HRM.
  10. 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 2 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 epithelium 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 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

Contact

Rachel Karlnoski
University of South Florida - Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606

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