Gastroesophageal Reflux Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Gastroesophageal Reflux Disease (GERD)
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.
The purpose of this investigation is to demonstrate the safety and effectiveness of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System in the treatment of subjects with gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled clinical investigation. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for a 6-month, double-blind phase followed by an additional open-label treatment phase in which all subjects will receive electrical stimulation therapy for a total of 12 months. Subjects continue on stimulation treatment and an extended open-label follow-up phase includes an 18 month post-stimulation phone interview followed by annual visits through 5 years post-stimulation. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05561179 -
Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease
|
N/A | |
| Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
| Completed |
NCT01946971 -
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01825473 -
Study of Erythromycin in GER-Associated Apnea of the Newborn
|
N/A | |
| Completed |
NCT00614536 -
Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
|
Phase 4 | |
| Completed |
NCT00284908 -
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00373997 -
Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
|
Phase 4 | |
| Completed |
NCT00365300 -
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
| Completed |
NCT00141960 -
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
|
Phase 2/Phase 3 | |
| Completed |
NCT01167543 -
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
|
N/A | |
| Completed |
NCT00567021 -
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
|
N/A | |
| Completed |
NCT00291746 -
Validation of RDQ Questionnaire
|
Phase 4 | |
| Completed |
NCT00226044 -
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
|
Phase 3 | |
| Completed |
NCT00215787 -
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
|
N/A | |
| Completed |
NCT01048840 -
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
|
||
| Completed |
NCT00181805 -
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
|
||
| Terminated |
NCT01281553 -
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
|
Phase 4 | |
| Completed |
NCT05486169 -
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
|
N/A | |
| Completed |
NCT04034017 -
Gastroesophageal Reflux Disease Among College Students
|
||
| Terminated |
NCT03226054 -
Determining Risk Factors for Successful PPI Weaning
|
N/A |