Thoracic disorders: Reflux Disease Gastroesophageale Reflux Disease and Reflux Disease
Conditions
Interventions
Laparoscopy:
During the laparoscopic study procedure, the study doctor will attach the
investigational device, called a stimulation lead, to the lower part of the
patients* esophagus. The study doct
Sponsors
EndoStim, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a. Subject is between 21 - 65 years of age. b. Subject has a history of heartburn, regurgitation or both for >6 month prompting physician recommendation of continual daily use of PPI before study entry. Baseline GERD HRQL heartburn score of >= 20 off PPI assessed during the run in phase. c. Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or II (or comparable local classification if any). d. Subject has demonstrated satisfactory symptomatic response to a previous course of GERD therapy (>= 2 weeks). GERD HRQL heartburn score improvement of > 10 on therapy as assessed within 6 weeks of enrollment. e. Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of antisecretory therapy performed within 6 months of enrollment; pH 5% of total time or > 3% of supine time. f. Subject has a resting LES end expiratory pressure > 5mm Hg and 30 mmHg for >70% of swallows and > 50% peristaltic contractions on high resolution manometry. i. Subject has signed the informed consent form.
Exclusion criteria
Exclusion criteria: a. Subject has any non-GERD esophageal motility disorders. b. Subject has gastroparesis. 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 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. History of previous esophageal or gastric surgery, including nissen fundoplication. t. Subject has any condition that, at the discretion of the investigator or sponsor, would preclude participation in the trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints: 1. Change in patient*s GERD-HRQL from baseline (as measured while off PPI) to 3 months. 2. The baseline LES end expiratory pressure (LESPpre) and the on-stimulation LES end expiratory pressure (LESPpost) at three months. 3. The baseline pH values of % 24-hour esophageal pH1minute and >5 minute duration with the same on-stimulation pH parameters at three months. 4. Baseline symptoms as measured by patient symptom diary and patients quality of life measured by SF-12 with on-stimulation symptoms and QOL at three months. 5. Decrease in antisecretory medication use compared to baseline. | — |
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) 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 Week 12 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 Functionality Endpoint: functionality will be assessed by the ability of the device to initiate stimulation as programmed and to accurately detect the patient*s posture. Indication of device detection when the patient is lying horizontally and when standing up will be recorded. | — |
Countries
Netherlands
Outcome results
None listed