Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

Completed

• Conditions: Gastrointestinal Diseases
• Interventions: Device: Recording of Myoelectric Signals

• Registration Number: NCT01697397
• Lead Sponsor: G-Tech Corporation

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 \[subjects without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain\].

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2015-11-30
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Results First Posted: 2024-01-23
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with and without FGIDs/IBS	Recording of Myoelectric Signals	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.

Primary Outcome Measures

Name	Time	Method
Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects.	Up to 4 hours at time of procedure	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. Subjects were grouped based on their diagnoses, and their mean peak volume profiles over time were calculated for each of the ranges.

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Outcome	Up to 4 hours at time of procedure	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.
Number of Anticipated, Un-Anticipated, and Serious Adverse Events	Up to 4 hours at time of procedure	Assess and record anticipated adverse events (AEs), unanticipated adverse device effects (UADEs), and serious adverse events (SAEs) at time of recording

Trial Locations

Locations (1)

G-Tech Corporation; 🇺🇸 Mountain View, California, United States