Trial record 1 of 1 for:
NCT02749071
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
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| ClinicalTrials.gov Identifier: NCT02749071 |
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Recruitment Status :
Terminated
(Company no longer operational)
First Posted : April 22, 2016
Last Update Posted : October 18, 2019
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Sponsor:
EndoStim Inc.
Information provided by (Responsible Party):
EndoStim Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) Reflux, Gastroesophageal Gastroesophageal Reflux Acid Reflux | Procedure: Laparoscopic implantation surgery Device: EndoStim stimulation for first six months of study Device: EndoStim stimulation from Month 6 thru end of study Device: Sham EndoStim stimulation for first six months of study | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 161 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | May 2016 |
| Actual Primary Completion Date : | October 2019 |
| Actual Study Completion Date : | October 2019 |
| Arm | Intervention/treatment |
|---|---|
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Sham Comparator: 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.
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Procedure: Laparoscopic implantation surgery
Laparoscopic surgery to implant the pulse generator and bipolar lead. Device: EndoStim stimulation from Month 6 thru end of study Lower esophageal stimulation
Other Names:
Device: Sham EndoStim stimulation for first six months of study EndoStim device remains "off" (no stimulation delivered) |
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Experimental: 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.
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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
Other Names:
Device: EndoStim stimulation from Month 6 thru end of study Lower esophageal stimulation
Other Names:
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Primary Outcome Measures :
- 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
- 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)
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| Ages Eligible for Study: | 22 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 >450.
- 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
- 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
- Any significant multisystem diseases
- 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
- 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
- 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.
- Significant cerebrovascular event within the last 6 months
- Existing implanted electrical stimulator (pacemaker, implantable cardioverter defibrillator, deep brain stimulator (DBS), bone growth or pelvic floor stimulators, drug pumps, etc.)
- 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
- Currently enrolled in other potentially confounding research
- Active infection as determined by the investigator
- History of any malignancy, other than basal cell carcinoma, in the last 2 years
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749071
Locations
Show 21 study locations
Sponsors and Collaborators
EndoStim Inc.
Investigators
| Principal Investigator: | Nicholas J Shaheen, MD, MPH | University of North Carolina |
Additional Information:
| Responsible Party: | EndoStim Inc. |
| ClinicalTrials.gov Identifier: | NCT02749071 |
| Other Study ID Numbers: |
CS-100 |
| First Posted: | April 22, 2016 Key Record Dates |
| Last Update Posted: | October 18, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Gastroesophageal Reflux Esophagitis, Peptic Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Esophagitis Gastroenteritis Peptic Ulcer Duodenal Diseases Intestinal Diseases Stomach Diseases |