Completed

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

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What is being collected

Device Data

Collected from today forward - Prospective
Device
Who is being recruted

Colonic Diseases+3

+ Colonic Diseases, Functional

+ Digestive System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2012
See protocol details

Summary

Principal SponsorG-Tech Corporation
Last updated: September 30, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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].

Principal SponsorG-Tech Corporation
Last updated: September 30, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesColonic Diseases, FunctionalDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesIrritable Bowel Syndrome

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

G-Tech Corporation

Mountain View, United StatesOpen G-Tech Corporation in Google Maps
CompletedOne Study Center