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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02500264
• Other study ID #: 0293-15-RMC
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2015
• Last updated: September 19, 2017
• Start date: August 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2017
• Source: Rabin Medical Center
• Contact: ram dickman, professor
• Phone: +97239377235
• Email: dickmanr[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Device:
• TENS

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Peta? Tiqwa

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment		34 days
Secondary	Esophageal acid exposure before and after treatment	Ph monitoring	34 days