Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

Gastrointestinal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697397
• Other study ID #: CLP-2012-001
• Status: Completed
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: April 2023
• Source: G-Tech Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Irritable Bowel Syndrome

Intervention

Device:
• Recording of Myoelectric Signals
Obtain recordings of the electrical signals of the gut.

Locations

Country	Name	City	State
United States	G-Tech Corporation	Mountain View	California

Sponsors (2)

Lead Sponsor	Collaborator
G-Tech Corporation	Eminence Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Triadafilopoulos, George, et al.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Subjects were grouped based on their diagnoses, and their mean peak volume profiles over time were calculated for each of the ranges.	Up to 4 hours at time of procedure
Secondary	Secondary Efficacy Outcome	The study was not powered to analyze the differences for the FGID conditions of constipation and diarrhea, but was for a group of subjects with gastroparesis and reflux disorder. For these two groups, the mean myoelectrical activity in the stomach, small intestine, and colon were calculated and compared to that of the health controls.	Up to 4 hours at time of procedure
Secondary	Number of Anticipated, Un-Anticipated, and Serious Adverse Events	Assess and record anticipated adverse events (AEs), unanticipated adverse device effects (UADEs), and serious adverse events (SAEs) at time of recording	Up to 4 hours at time of procedure