Back to resultsThe Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
Primary Purpose
Gastroesophageal Reflux Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease
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)
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Protocol #1
Protocol #2
Protocol #3
Protocol #4
Arm Description
interventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium
1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium
1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique
1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium
Outcomes
Primary Outcome Measures
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
Secondary Outcome Measures
Esophageal acid exposure before and after treatment
Ph monitoring
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02500264
Brief Title
The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
Official Title
The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protocol #1
Arm Type
Active Comparator
Arm Description
interventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium
Arm Title
Protocol #2
Arm Type
Active Comparator
Arm Description
1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium
Arm Title
Protocol #3
Arm Type
Active Comparator
Arm Description
1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique
Arm Title
Protocol #4
Arm Type
Active Comparator
Arm Description
1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium
Intervention Type
Device
Intervention Name(s)
TENS
Primary Outcome Measure Information:
Title
Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
Time Frame
34 days
Secondary Outcome Measure Information:
Title
Esophageal acid exposure before and after treatment
Description
Ph monitoring
Time Frame
34 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ram dickman, professor
Phone
+97239377235
Email
dickmanr@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
maor pauker, Dr.
Phone
+97235056708
Email
maorha11@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ram dickman, professor
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petaẖ Tiqwa
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ram dickman, professor
Phone
+97239377235
Email
dickmanr@clalit.org.il
First Name & Middle Initial & Last Name & Degree
maor pauker, Dr.
Phone
+97235056708
Email
maorha11@clalit.org.il
First Name & Middle Initial & Last Name & Degree
ram dickman, professor
First Name & Middle Initial & Last Name & Degree
amani bashara, Dr.
12. IPD Sharing Statement
Learn more about this trial
The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
We'll reach out to this number within 24 hrs