Clinical trial NCT01697397: Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Diseases
Keywords: Irritable bowel syndrome
IBS
Gastrointestinal pain
Gastrointestinal functional disorder
Lead sponsor: G-Tech Corporation
Sponsor class: INDUSTRY
Collaborators: name: Eminence Clinical Research, Inc.
First posted: 2012-10-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Irritable bowel syndrome, functional bowel disorder.

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.

Detailed 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 \[subjects without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain\].

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.

Primary outcomes:
measure: Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects.
timeFrame: Up to 4 hours at time of procedure
Secondary outcomes:
measure: Secondary Efficacy Outcome
timeFrame: Up to 4 hours at time of procedure
measure: Number of Anticipated, Un-Anticipated, and Serious Adverse Events
timeFrame: Up to 4 hours at time of procedure
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: G-Tech Corporation
state: California
Study officials:
affiliation: G-Tech Chief Medical Officer and Medical Monitor
name: Prince Shah, MD
role: STUDY_CHAIR
References:
citation: Triadafilopoulos, George, et al.