Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01697397
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : August 13, 2015
Eminence Clinical Research, Inc.
Information provided by (Responsible Party):
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.

Condition or disease
Gastrointestinal Diseases

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].

Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : July 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Primary Outcome Measures :
  1. Device Success defined as the ability to record myoelectric signals in study subjects. [ Time Frame: Procedure ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Irritable bowel syndrome, functional bowel disorder.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01697397

United States, California
G-Tech Corporation
Mountain View, California, United States, 94040
Sponsors and Collaborators
G-Tech Corporation
Eminence Clinical Research, Inc.
Study Chair: Prince Shah, MD G-Tech Chief Medical Officer and Medical Monitor

Additional Information:
Anand Navalgund, PhD, Steve Axelrod, PhD, George Triadafilopoulos, MD2Feasibility of measuring the contractile electrical complex over 72 hours in a healthy human subject using a wearable, wireless electrode patch. Abstract submitted to AGA IBS Conference 2015.

Responsible Party: G-Tech Corporation Identifier: NCT01697397     History of Changes
Other Study ID Numbers: CLP-2012-001
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by G-Tech Corporation:
Irritable bowel syndrome
Gastrointestinal pain
Gastrointestinal functional disorder

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases