K21
Conditions
Interventions
Group 1: Patients with therapy-resistant GERD/dysphagie undergoing a Re-Do procedure with implantation of the EndoStim-LESS system, treatment according to routine care.
Evaluation with high resolutio
Sponsors
EndoStim Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: I. Subject is 18 – 65 years of age at the time of informed consent II. Subject must be able and willing to provide written informed consent III. Subject has undergone a fundoplication in the past (Nissen or Toupet). Between fundoplication and inclusion into this study at least 6 months have to have passed. IV. No more than 6 months before Re-Do procedure: indication for a re-do intervention was determined during an interdisciplinary consultation with objective proof of symptoms and comprehensive gastro-enterological diagnostic. V. No more than 6 months before Re-Do procedure: impedance pH measurement showed a low esophageal acid exposure (pH < 4 in the distal esophagus in = 5,0% of the measurements), at minimum 14 days after discontinuing PPI and 2 days of discontinuing H2 blocker. VI. No more than 6 months before Re-Do procedure: A high resolution manometry (HRM) or a classic manometry of the esophagus was performed VII. No more than 6 months before Re-Do procedure: Objective findings of dysphagia caused by reflux. VIII. If the leading symptom was dysphagia, at least one balloon dilatation intervention was attempted to resolve the problem. IX. Subject is a suitable surgical candidate able to undergo laparoscopic surgery and implantation of the EndoStim LES stimulation system
Exclusion criteria
Exclusion criteria: I. Subject had a previous EndoStim LES System implant and/or implant attempt II. Female subject of child-bearing potential and is pregnant or nursing, or intends to become pregnant during the trial period, and/or is not using a reliable form of birth control III. Subject is currently enrolled in another research study IV. Subject underwent previous endoscopic intervention for the treatment of GERD and/or a Barrett’s esophagus. V. Other diseases of the upper gastrointestinal tract VI. Subject has suspected or known allergies to titanium, platinum, iridium, stainless steel, silicone, epoxy, or nylon VII. Subject has an active infection confirmed by the investigator VIII. The subject is diagnosed with an upside-down stomach (Gastric volvulus) IX. Subject has a known history of gastroparesis X. The subject is diagnosed with a large hiatal hernia that would need a mesh augmentation. XI. Subject has any non-GERD esophageal motility disorders that in the opinion of investigator preclude an anti-reflux procedure XII. Subject has history of or known esophageal stricture or significant esophageal anatomic abnormalities (obstructive lesions, etc.) XIII. Subject has Barrett’s epithelium with any grade of dysplasia. XIV. Subject has a history of suspected or confirmed esophageal or gastric cancer XV. Subject has esophageal or gastric varices (grade II or larger) XVI. Subject has an 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 XVII. Subject has 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. XVIII. Subject has had a significant cerebrovascular event within the last 6 months XIX. Subject has an existing implanted electrical stimulator (pacemaker, implantable cardioverter defibrillator, DBS, bone growth or pelvic floor stimulators, drug pumps, etc.) XX. Subject has a history of any malignancy with a life expectancy < 1 year XXI. Subject has a diagnosed major untreated psychiatric disorder (bipolar, schizophrenia, etc.) XXII. Subject has any condition that, at the discretion of the investigator, would interfere with accurate interpretation of the study endpoints or preclude participation in the trial XXIII. Subject is imprisoned XXIV. Subject with alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: - Improvement of the GERD-HRQL score for patients with the leading symptom reflux -Improvement of the Mayo-Clinical-Dysphagia Score for patient with the leading symptom dysphagia Safety: - Safety Endpoint: Comparison of rate of occurrence of device- and/or procedure-related serious adverse events (SAEs) postoperatively and at the 12-months follow-up visit as adjudicated by the Data Safety Monitoring Board. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Frequency and seriousness of regurgitation symptoms (day and night), heartburn symptoms, and dysphagia according to the patient’s diary entries (for 10 days prior to the visit) whilst stopping PPI therapy. -Change in pH as measured by % exposure to pH < 4 comparing pre- and post EndoStim implant. - All secondary adverse events of the procedure (i.e. lead dislocation at the implant site, secondary perforations of the esophagus, internal hernias, dumping, ulcerations) | — |
Countries
Germany
Contacts
Public ContactFrank Willeke
St. Marien-Krankenhaus Siegen gem GmbHChirurgische Klinik
Outcome results
None listed