Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by G-Tech Corporation
Sponsor:
Collaborator:
Eminence Clinical Research, Inc.
Information provided by (Responsible Party):
G-Tech Corporation
ClinicalTrials.gov Identifier:
NCT01697397
First received: September 28, 2012
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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
Irritable Bowel Syndrome
Gastrointestinal Pain
GI Discomfort

Study Type: Observational
Study Design: 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 (IBS) AND REPORTS OF GI PAIN AND ASYMPTOMATIC SUBJECTS WITHOUT IBS AND GI PAIN

Further study details as provided by G-Tech Corporation:

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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].

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Irritable bowel syndrome, functional bowel disorder.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697397

Contacts
Contact: Steve Axelrod, PhD (650) 269-1479 steve.axelrod@gtechhealth.com

Locations
United States, California
G-Tech Corporation Recruiting
Palo Alto, California, United States, 94303
Contact: Steve Axelrod, PhD    650-269-1479    steve.axlerod@gtechhealth.com   
Principal Investigator: Steve Axelrod, PhD         
Sponsors and Collaborators
G-Tech Corporation
Eminence Clinical Research, Inc.
Investigators
Study Chair: Roger Sahm, MD G-Tech Chief Medical Officer and Medical Monitor
  More Information

Additional Information:
No publications provided

Responsible Party: G-Tech Corporation
ClinicalTrials.gov Identifier: NCT01697397     History of Changes
Other Study ID Numbers: CLP-2012-001
Study First Received: September 28, 2012
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 25, 2014