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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500264
Recruitment Status : Unknown
Verified September 2017 by Ram Dickman, Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : July 16, 2015
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ram Dickman, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Device: TENS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
Study Start Date : August 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: Protocol #1
interventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium
Device: TENS
Active Comparator: Protocol #2
1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium
Device: TENS
Active Comparator: Protocol #3
1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique
Device: TENS
Active Comparator: Protocol #4
1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium
Device: TENS



Primary Outcome Measures :
  1. Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment [ Time Frame: 34 days ]

Secondary Outcome Measures :
  1. Esophageal acid exposure before and after treatment [ Time Frame: 34 days ]
    Ph monitoring



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500264


Contacts
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Contact: ram dickman, professor +97239377235 dickmanr@clalit.org.il
Contact: maor pauker, Dr. +97235056708 maorha11@clalit.org.il

Locations
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Israel
Rabin Medical Center Recruiting
Petaẖ Tiqwa, Israel, 4941492
Contact: ram dickman, professor    +97239377235    dickmanr@clalit.org.il   
Contact: maor pauker, Dr.    +97235056708    maorha11@clalit.org.il   
Principal Investigator: ram dickman, professor         
Sub-Investigator: amani bashara, Dr.         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: ram dickman, professor MD
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Responsible Party: Ram Dickman, Gastroenterologist, manager of the GI movement service in RMC, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02500264    
Other Study ID Numbers: 0293-15-RMC
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases