Gastroesophageal Reflux Disease
Conditions
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.
Interventions
DEVICETENS
Sponsors
Rabin Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment | 34 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal acid exposure before and after treatment | 34 days | Ph monitoring |
Countries
Israel
Contacts
Primary Contactram dickman, professor
Backup Contactmaor pauker, Dr.
Outcome results
None listed