Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

NCT ID: NCT01697397

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-06-30

Brief Summary

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.

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].

Conditions

Gastrointestinal Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Recording of Myoelectric Signals

Intervention Type: DEVICE

Obtain recordings of the electrical signals of the gut.

Interventions

Recording of Myoelectric Signals

Obtain recordings of the electrical signals of the gut.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

No prior diagnosis IBS; No complaints of GI pain.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eminence Clinical Research, Inc.

INDUSTRY

Sponsor Role: collaborator

G-Tech Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prince Shah, MD

Role: STUDY_CHAIR

G-Tech Chief Medical Officer and Medical Monitor

Locations

G-Tech Corporation

Mountain View, California, United States

Countries

United States

References

Triadafilopoulos, George, et al.

Reference Type: RESULT

Other Identifiers

CLP-2012-001

Identifier Type: -

Identifier Source: org_study_id