Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

Study Overview
=================
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, 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].

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

Conditions
-----------------
Gastrointestinal Diseases

Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
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. |  | Procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable bowel syndrome, IBS, Gastrointestinal pain, Gastrointestinal functional disorder