Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

NCT01697397 | Completed Results

• 1 other identifier: CLP-2012-001
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases

Keywords

Irritable bowel syndrome; IBS; Gastrointestinal pain; Gastrointestinal functional disorder

Outcome Measures

Primary Outcomes (1)

• Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects.

  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. The patches measure the myoelectric voltage present at the skin surface to determine the motor activity of each organ. The unit of measure for the activity is (mV)\*\*2 X Hz. This is a standard measurement used in frequency spectrum analysis.

  Up to 4 hours at time of procedure

Secondary Outcomes (2)

• Secondary Efficacy Outcome

  Up to 4 hours at time of procedure

• Number of Anticipated, Un-Anticipated, and Serious Adverse Events

  Up to 4 hours at time of procedure

Study Arms (1)

Patients with and without FGIDs/IBS

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.

Device: Recording of Myoelectric Signals

Interventions

Recording of Myoelectric Signals DEVICE

Obtain recordings of the electrical signals of the gut.

Patients with and without FGIDs/IBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Irritable bowel syndrome, functional bowel disorder.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Control Subjects Eligibility Criteria Subjects who do NOT have a prior diagnosis of functional GI disorder
• No prior diagnosis IBS; No complaints of GI pain.

Sponsors & Collaborators

• G-Tech Corporation: lead
• Eminence Clinical Research, Inc.: collaborator

Study Sites (1)

G-Tech Corporation

Mountain View, California, 94040, United States

Location

Related Publications (1)

• Triadafilopoulos, George, et al.

  RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

This 3 hour clinical trial was carried out as an investigation to determine the viability of a wireless, waterproof patch based system. 3 days of data would provide full coverage of all GI events, and nearly 5x the statistical precision of this test.

Results Point of Contact

• Title: Steve Axelrod, PhD, CEO
• Organization: G-Tech Medical

steve.axelrod@gtechhealth.com

650-269-1479

Study Officials

• Prince Shah, MD

  G-Tech Chief Medical Officer and Medical Monitor

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 30, 2025
• Results First Posted: January 23, 2024

Record last verified: 2025-09

Locations

US (1)