The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedSeptember 20, 2017
September 1, 2017
3.2 years
July 1, 2015
September 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
34 days
Secondary Outcomes (1)
Esophageal acid exposure before and after treatment
34 days
Study Arms (4)
Protocol #1
ACTIVE COMPARATORinterventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium
Protocol #2
ACTIVE COMPARATOR1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium
Protocol #3
ACTIVE COMPARATOR1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique
Protocol #4
ACTIVE COMPARATOR1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin Medical Center
Petah Tikva, 4941492, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ram dickman, professor
MD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterologist, manager of the GI movement service in RMC
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 16, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
September 20, 2017
Record last verified: 2017-09