NCT02500264
Unknown
Not Applicable
The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
ConditionsGastroesophageal Reflux Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Rabin Medical Center
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
- Last Updated
- 8 years ago
Overview
Brief Summary
The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure.
Investigators
Ram Dickman
Gastroenterologist, manager of the GI movement service in RMC
Rabin Medical Center
Eligibility Criteria
Inclusion Criteria
- •at least 3 episodes of heartburn and/or regurgitation in a week for at least 3 months.
- •evidence for an abnormal esophagal acid exposure on impedance-pH monitoring (tested in the last 2 years off PPI)
Exclusion Criteria
- •gastric or esophagal surgery
- •active peptic ulcer disease
- •malignancy
- •pregnancy
- •uncontrolled diabetes mellitus
- •severe cardiac conditions such as cardiac arrhythmia or ischemia or cardiac pacemaker/defibrillator
- •allergy to adhesives/patches
- •severe pulmonary disease
- •obesity (BMI\>30)
Outcomes
Primary Outcomes
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
Time Frame: 34 days
Secondary Outcomes
- Esophageal acid exposure before and after treatment(34 days)
Study Sites (1)
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