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

NCT ID: NCT02500264

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-10-31

Brief Summary

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

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Protocol #1

interventions: 1.6Hz, Rampdown 0.4S, electrodes position - both L.Rectus Abdominis, 5cmX5cm Size, on inspirium

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

Protocol #2

1Hz, Rampdown 0.6S, electrodes position - both Rectus Abdominis, 5cmX5cm Size, on inspirium

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

Protocol #3

1.6Hz, Rampdown 0.4S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium Oblique

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

Protocol #4

1Hz, Rampdown 0.6S, electrodes position - L.Rectus Abdominis and L.External Oblique, 5cmX5cm Size, on inspirium

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

Interventions

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TENS

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ram Dickman

Gastroenterologist, manager of the GI movement service in RMC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ram dickman, professor

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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ram dickman, professor

Role: CONTACT

[email protected]
+97239377235

maor pauker, Dr.

Role: CONTACT

[email protected]
+97235056708

Facility Contacts

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ram dickman, professor

Role: primary

[email protected]
+97239377235

maor pauker, Dr.

Role: backup

[email protected]
+97235056708

Other Identifiers

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0293-15-RMC

Identifier Type: -

Identifier Source: org_study_id