Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (GERD)
NCT ID: NCT02514616
Last Updated: 2015-11-20
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
1 participants
INTERVENTIONAL
2015-01-31
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of subjects with gastroesophageal reflux disease (GERD).
The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn, regurgitation or both for \> 6 months, on a daily PPI use.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Multicenter, randomized, double-blind, sham-controlled study. All subjects undergo screening and baseline visits, followed by system implantation, and randomization after 2 weeks to either a treatment Group (stimulation) or Control Group (delayed stimulation).
Randomized subjects complete a 10-week, double-blind phase. At the 14-week visit, subjects are unblinded, control group subjects begin receiving stimulation, and all subjects are followed for an additional 9-month open-label treatment phase.
Subjects continue receiving stimulation for an extended follow-up phase involving annual visits through 5 years.
Study Visits:
Screening and baseline visits. Laparoscopic implantable pulse generator (IPG) and lead implant procedure. Post-implant follow-up office visits at 2 weeks/randomization, 6, 10, 14, 24 and 48 weeks, followed by annual visits through 5 years.
Sample Size and Scope:
Forty-six subjects will be implanted and followed to 12 months after stimulation treatment at 3 investigational sites.
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
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Electric Stimulation Therapy
The subject receives Active Electric Stimulation Therapy for 12 weeks, 2 weeks after laparoscopic IPG and lead implant procedure. The subject and physician will be blinded to the randomization group assignment. The subject continues on stimulation treatment after 14 weeks and an extended open-label follow-up phase includes annual visits through 5 years.
Laparoscopic IPG and lead implant procedure
EST placement
Active Electric Stimulation Therapy
Device programming by the technician to deliver the EST system active (Treatment group) or no stimulation (Control group) for the following 12 weeks, at the 2 weeks visit.
Delayed Electric Stimulation Therapy
The subject receives no active Electric Stimulation Therapy for 12 weeks, 2 weeks after laparoscopic IPG and lead implant procedure. The subject and physician will be blinded to the randomization group assignment. The subject will receive Active Electric Stimulation Therapy at week 14 visit, and an extended open-label follow-up phase includes annual visits through 5 years.
Laparoscopic IPG and lead implant procedure
EST placement
Delayed Electric Stimulation Therapy
Device programming by the technician to deliver the EST system no stimulation for the following 12 weeks at the 2 weeks visit. Active Electric Stimulation Therapy will be programmed at the 14 weeks visit.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laparoscopic IPG and lead implant procedure
EST placement
Active Electric Stimulation Therapy
Device programming by the technician to deliver the EST system active (Treatment group) or no stimulation (Control group) for the following 12 weeks, at the 2 weeks visit.
Delayed Electric Stimulation Therapy
Device programming by the technician to deliver the EST system no stimulation for the following 12 weeks at the 2 weeks visit. Active Electric Stimulation Therapy will be programmed at the 14 weeks visit.
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
* Subject able and willing to comply with required study procedures and follow-up schedule
* Typical symptoms of GERD (regurgitation and/or heartburn) for longer than 6 months, heartburn responding to PPI therapy. Subject may also complain of atypical symptoms of GERD that may persist on PPI
* Daily dose of PPI or other acid neutralization drugs because of PPI intolerance
* Baseline visit GERD-HRQL score ≥ 20 following 14 days off-PPI and at least 10 points higher than their on-PPI (or other acid-neutralization drugs) GERD-HRQL score recorded during the Screening Visit
* Excessive lower esophageal acid exposure during pH monitoring (defined as distal esophageal pH \< 4 for \> 5.0% of the monitoring time) performed after 14 days off PPIs
* Subject is a suitable surgical candidate able to undergo general anesthesia and laparoscopic surgery.
Exclusion Criteria
* Previous esophageal surgery, including Nissen fundoplication
* Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
* Hiatal hernia larger than 2 cm as determined by any diagnostic investigation (i.e., endoscopy, manometry or laparoscopic visualization)
* Gastroparesis
* Any non-GERD esophageal motility disorders
* Esophageal stricture or significant esophageal anatomic abnormalities
* Barrett's epithelium 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 within the last 3 months
* 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, or has T2DM for \> 10 years
* Significant cardiac arrhythmia or ectopy or significant cardiovascular disease (i.e. unstable angina pectoris, hemodynamically significant valvular disease, severe congestive heart failure), or 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.)
* Chronic anticoagulant therapy
* 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
* Subject is currently enrolled in other potentially confounding research
* Active infection as determined by the investigator
* History of any malignancy in the last 2 years
* Life expectancy less than 3 years
* Diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.)
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EndoStim Inc.
INDUSTRY
Erasme University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hubert Louis
Hubert LOUIS, pHD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gastroenterology Department, Erasme University Hospital
Brussels, , Belgium
Hôpital Edouard Herriot, Service d'Explorations Fonctionnelles Digestives, Pavillons H et L, 5 Place d'Arsonval
Lyon, Lyon Cedex 3, France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ESE-001
Identifier Type: -
Identifier Source: org_study_id