Not provided
Not provided
Not provided
Not provided
Early termination due to a suspension of financial support
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| EndoStim Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigational device that will be used in this trial is the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System.
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.
Study Design:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Electric Stimulation Therapy | Active Comparator | 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. |
|
| Delayed Electric Stimulation Therapy | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic IPG and lead implant procedure | Procedure | EST placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of EST on GERD symptoms (mean improvement in the GERD- health-related quality of life (HRQL) scores from baseline in control and treatment groups) | Comparison between Treatment and Control Groups of the mean improvement in the composite GERD-HRQL scores from baseline measured after at least 14 days off proton pump inhibitors (PPIs) | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Rate of occurrence of device- and procedure-related adverse events) | 12 months | |
| Number of subjects achieving GERD symptom success | Improvement in the total GERD-HRQL score of 50% or more compared to pre-implantation score off PPI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Department, Erasme University Hospital | Brussels | 1070 | Belgium | |||
| Hôpital Edouard Herriot, Service d'Explorations Fonctionnelles Digestives, Pavillons H et L, 5 Place d'Arsonval |
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Electric Stimulation Therapy | Device | 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 | 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. |
|
|
| 12 months |
| Reflux symptoms measured by GERD-HRQL score | Mean improvement in the composite GERD-HRQL scores from baseline measured after at least 14 days off proton pump inhibitors (PPIs) | 6 months |
| Reflux symptoms measured by GERD-HRQL score | Mean improvement in the composite GERD-HRQL scores from baseline measured after at least 14 days off proton pump inhibitors (PPIs) | 12 months |
| Number of subjects able to stop regular use of acid-suppression | Defined as 50% or more days without PPI use | 12 months |
| Number of subjects able to stop all use of acid-suppression medication | 12 months |
| Percentage of asymptomatic patients | Defined as an improvement in their total GERD-HRQL score of 50% or more compared to pre-implantation score off PPI) in treatment and control groups, off-PPI for the last 2 weeks. | 14 weeks |
| Incidence of reflux esophagitis | 12 months |
| Quality of life measured by EQ-5D EuroQol score | Difference in patient's EQ-5D score, compared to pre-implantation score on and off PPI. | 14 weeks |
| Quality of life measured by EQ-5D score | Difference in patient's EQ-5D score, compared to pre-implantation score on and off PPI. | 6 months |
| Quality of life measured by EQ-5D score | Difference in patient's EQ-5D score, compared to pre-implantation score on and off PPI. | 12 months |
| Efficacy of EST on acid reflux measured by esophageal pH | Difference in % 24 hour esophageal pH<4 in Treatment and Control groups (total, upright, supine, postprandial (2h)). | 14 weeks |
| Efficacy of EST on acid reflux measured by DeMeester score | Difference in DeMeester score in Treatment and Control groups. | 14 weeks |
| Percentage of subjects achieving pH success | Defined as normalization (pH < 4 for no more than 4.1% of monitoring time) or > 50% improvement in their distal esophageal acid exposure compared to their baseline off-PPI distal esophageal pH. | 14 weeks |
| Efficacy of EST on reflux episodes measured by esophageal impedance | Difference in the number of reflux episodes (total, upright, supine, postprandial (2h), acidic, weakly acidic, weakly alkaline, and proximal extent (15 cm) in Treatment and Control groups. | 14 weeks |
| Difference in lower esophageal sphincter (LOS) pressure and integrated relaxation pressure at 4 seconds (IRP4s) in Treatment and Control groups | 14 weeks |
| Comparison of GERD-HRQL scores in Treatment and Control groups | 14 weeks |
| Comparison of quality of life measured by EQ-5D in Treatment and Control groups | 14 weeks |
| Lyon |
| Lyon Cedex 3 |
| 69437 |
| France |
| D004066 | Digestive System Diseases |