N/A N=88

Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol

Gastrointestinal Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01697397 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects. — 88 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Recording of Myoelectric Signals (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: G-Tech Corporation
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects.	88	—
SECONDARY Secondary Efficacy Outcome	2.14; 0.75; 0.78; 1.24; 1.89; 1.61	—
SECONDARY Number of Anticipated, Un-Anticipated, and Serious Adverse Events	—	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01697397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.