Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

A Feasibility Study For Monitoring And Recording Gastrointestinal Myoelectric Activity In Subjects With Suspected Or Diagnosed Irritable Bowel Syndrome (IBS) And Reports Of GI Pain And Asymptomatic Subjects Without IBS and GI Pain

A feasibility study for monitoring and recording gastrointestinal (GI) myoelectric activity in subjects with suspected or diagnosed irritable bowel syndrome (IBS) and reports of GI pain and asymptomatic subjects without IBS and GI pain.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Device: Recording of Myoelectric Signals

Detailed Description

This single arm, prospectively enrolling, non-randomized feasibility study has been designed to transcutaneously detect and monitor myoelectric intestinal signals temporally associated with the symptoms of patients who report pain and have suspected or diagnosed IBS, and in controls [subjects without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain].

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • G-Tech Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Irritable bowel syndrome, functional bowel disorder.

Description

General Eligibility Criteria:

General Inclusion Criteria

• Willing and able to provide informed consent;
• Eighteen (18) years of age or older;
• Willing and able to follow a specified study procedure regimen;
• No known allergy to commercially available food or drink required by specified study procedure regimen;
• Willing and able to recline and remain still during the recordings.

General Exclusion Criteria

• Subject has an implantable device such as a pacemaker, defibrillator, nerve stimulator, insulin pump, automatic analgesic pump, or other automated implanted medical device;
• Known allergy to isopropyl (rubbing) alcohol;
• Known allergy to Ag/AgCl electrodes;
• Known allergy to glue adhesive (electrode adhesive);
• Dietary restrictions not permitting intake of food or drink required by this protocol;
• Dietary restrictions not permitting four (4) hour fasting period prior to start of myoelectric recording;
• Subject is pregnant or suspects pregnancy;
• Open sores or wounds on the abdomen;
• Any injury in or around the area of electrode placement that would cause pain with gentle pressure required for electrode and lead wire placement;
• Weight > 300 lbs (136 Kg) (excess weight can interfere with quality of the signals).

IBS With Complaints of GI Pain Eligibility Criteria IBS With Complaints of Pain Inclusion Criteria All answers must be "YES" to the All of the Following Inclusion Criteria Prior diagnosis of IBS and complaints of GI pain IBS With Complaints of Pain Exclusion Criteria All answers must be "NO" to the All of the Following Exclusion Criteria Functional dyspepsia; No reports of GI pain, past or present.

Control Subjects Eligibility Criteria Subjects who do NOT have a prior diagnosis of functional GI disorder

Control Subjects Inclusion Criteria All answers must be "YES" to the All of the Following Inclusion Criteria

No prior diagnosis IBS; No complaints of GI pain.

Control Subjects Exclusion Criteria All answers must be "NO" to the All of the Following Exclusion Criteria Current diagnosis of any GI disorder; Current or recent complaints of GI pain.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with and without FGIDs/IBS; Patients with functional gastro-intestinal disorders (FGIDs) undergo recording of myoelectric signals before, during, and after a meal. In addition, patients without FGIDs undergo recording of myoelectric signals before, during, and after a meal.	Device: Recording of Myoelectric Signals; Obtain recordings of the electrical signals of the gut.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects.	All patients in the study received the investigational device for recording myoelectric signals. Patients had a variety of symptoms and diagnoses, among which the mean peak volume profiles for a group of subjects with gastroparesis (7 tests) and reflux disorder (9 tests) were identified and analyzed separately. Subjects were fed a 700 kCal meal 60 minutes into the test. Time-dependent peaks in the frequency spectra were identified and volumes (height x width x duration) were calculated from data obtained in 101 tests of FGID patients and controls. Peaks were associated with each of the digestive organs in frequency ranges as follows for stomach: 2-4 cycles per min. (cpm); small intestine: 5-12 cpm; and colon: 12-25 cpm. The patches measure the myoelectric voltage present at the skin surface to determine the motor activity of each organ. The unit of measure for the activity is (mV)**2 X Hz. This is a standard measurement used in frequency spectrum analysis.	Up to 4 hours at time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Outcome	The study was not powered to analyze the differences for the FGID conditions of constipation and diarrhea, but was for a group of subjects with gastroparesis and reflux disorder. For these two groups, the mean myoelectrical activity in the stomach, small intestine, and colon were calculated and compared to that of the health controls.	Up to 4 hours at time of procedure
Number of Anticipated, Un-Anticipated, and Serious Adverse Events	Assess and record anticipated adverse events (AEs), unanticipated adverse device effects (UADEs), and serious adverse events (SAEs) at time of recording	Up to 4 hours at time of procedure

Collaborators and Investigators

• Sponsor: G-Tech Corporation
• Collaborators: Eminence Clinical Research, Inc.
• Investigators: Study Chair: Prince Shah, MD, G-Tech Chief Medical Officer and Medical Monitor

Publications and helpful links

General Publications

• Triadafilopoulos, George, et al.

Helpful Links

• Description of functional GI disorders, and detailed description of myoelectric science.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 28, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimated): October 2, 2012

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: IBS; Irritable bowel syndrome; Gastrointestinal pain; Gastrointestinal functional disorder
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Gastrointestinal Diseases
• Other Study ID Numbers: CLP-2012-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Present in abstracts at society meetings and enter on-line on this website.