An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD) (CS005)
Phase 2
Completed
- Conditions
- Heartburn10017977
- Registration Number
- NL-OMON36042
- Lead Sponsor
- EndoStim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Subject has a history of heartburn, regurgitation or both for >6 month. Baseline GERD HRQL heartburn score of >= 20 off PPI assessed during the run in phase.
Excessive acid exposure during 24-hour pH-metry of antisecretory therapy
Exclusion Criteria
Subject has any non-GERD esophageal motility disorders.
Subject has gastroparesis.
Subject has a hiatal hernia larger than 3 cm.
Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
Subject is pregnant or intends to become pregnant during the trial period.
History of previous esophageal or gastric surgery, including nissen fundoplication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method