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Clinical Trials/NCT02500264
NCT02500264
Unknown
Not Applicable

The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study

Rabin Medical Center1 site in 1 country12 target enrollmentAugust 2015

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
October 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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