Heartburn
Conditions
Interventions
Implantation of the EndoStim stimulation device and electrical stimulation
therapy
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a. Subject is between 18 * 80 years of age. b. Subject underwent a sleeve gastrectomy minimum one year prior to enrollment (in order to have reached a stable weight loss plateau). c. Subject has a history of heartburn, regurgitation or both for >6 month prompting physician recommendation of continual daily use of PPI after sleeve gastrectomy. d. Baseline off-PPI GERD-HRQL score * 20 following 10-14 days off PPI e. Baseline off-PPI GERD-HRQLscore is at least 5 points higher than the on-PPI score or a positive relationship between the occurrence of their primary symptom during the pH impedance monitoring (symptom association probability * 95% or a SI score * 50%) is present. f. Subject who are on standard medical therapy for 6 months or longer and experience discomfort or who are otherwise dissatisfied with GERD symptoms. g. Subjects with a GERD condition that in the opinion of the PI justifies a minimally invasive reversible procedure prior to attempting a more drastic procedure such as a gastric bypass. h. Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of antisecretory therapy performed within 6 months of screening visit; pH 6% of total time. i. Subject has a resting LES end expiratory pressure * 5mmHg on manometry performed within 6 months of enrollment. j. Subject has no esophagitis or esophagitis * Grade C (LA classification) on upper endoscopy within 6 months of enrollment. k. Subject has esophageal body contraction amplitude > 30 mmHg for >30% of swallows and > 30% peristaltic contractions on manometry. l. Subject has signed the informed consent form and is able to adhere to study visit schedule.
Exclusion criteria
Exclusion criteria: a. Subject has any non-GERD esophageal motility disorders. b. Subject has evidence of obstruction or stricture in the gastric sleeve by a barium swallow and endoscopy. c. Subject has any significant multisystem diseases. d. Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma, dematomyositis, Calcinosis-Raynaud*s-Esophagus Sclerodactyly Syndrome (CREST), Sjogren*s Syndrome, Sharp*s Syndrome) requiring therapy in the preceding 2 years. e. Subject has Barrett*s epithelium (> M2; >C1) or any grade of dysplasia. f. Subject has a hiatal hernia larger than 3 cm. g. Subject has a body mass index (BMI) greater than 35 kg/m2. h. Subject has Type 1 Diabetes Mellitus i. Subject has uncontrolled Type 2 Diabetes Mellitus (T2DM) defined as HbA1c >9.5 in the previous 6 months, or has T2DM for > 10 years. j. Subject has a history of suspected or confirmed esophageal or gastric cancer. k. Subject has esophageal or gastric varices. l. Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease. m. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD). n. Subject requires chronic anticoagulant therapy. o. Subject has dysphagia or esophageal peptic stricture, excluding Schatzki*s ring. p. Subject of child-bearing potential who is pregnant or intends to become pregnant during the trial period. q. Subject is currently enrolled in other potentially confounding research. r. History of any malignancy in the last 2 years. s. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial. t. Weight change of +/- 10% of the EWL (Excess Weight Loss) in the 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: Safety will be assessed by the incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period. Safety will be assessed by incidence and severity of adverse events through 6 months follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device implant and completion of the month 6 evaluation: (1) death, or (2) medical morbidity associated with the device and/or implantation procedure, including cardiac arrhythmias, pneumonia, wound infection, IPG or lead perforation, or significant lead dislocation requiring hospitalization. Safety variables will be tabulated and presented for all patients in the treatment group. Number of patients undergoing device implantation and any reasons for discontinuation of study treatment will be tabulated Primary Efficacy Endpoint: The primary efficacy endpoint is the change in patient*s GERD-HRQL, where applicable, from baseline (as measured while off PPI) to 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes between the following values: 1. The baseline pH values of % 24-hour esophageal pH1minute and >5 minute duration with the same on-stimulation pH parameters at 6 months and at 12 months. 2. Change in symptoms frequency and severity at 6 months vs. baseline and at 12 months vs. baseline as measured by patient symptom diary, structured GI questionnaire, and patients quality of life measured by SF-12. 3. Change in anti-secretory medication use as evaluated during the two weeks prior to the 6 mo and 12 mo follow up compared to baseline. 4. The baseline LES end expiratory pressure (LESPpre) and the on-stimulation LES end expiratory pressure (LESPpost) at 6 months and 12 months 5. One year (12 mo) efficacy GERD- HRQL | — |
Countries
Netherlands
Outcome results
None listed