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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Sponsor
- EndoStim Inc.
- Enrollment
- 161
- Locations
- 21
- Primary Endpoint
- 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)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able and willing to provide written informed consent
- •Able and willing to comply with required study procedures and follow-up schedule
- •22 - 75 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.
- •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.
- •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 \>
- •Suitable surgical candidate able to undergo general anesthesia and laparoscopic surgery
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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)
Time Frame: Comparison of 6 months to baseline data
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)
Rate of device and/or procedure-related serious adverse events
Time Frame: 12 months
Rate of occurrence of device and/or procedure-related serious adverse events after 12 months