Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol
Verified October 2012 by G-Tech Corporation
Eminence Clinical Research, Inc.
Information provided by (Responsible Party):
First received: September 28, 2012
Last updated: March 12, 2015
Last verified: October 2012
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.
||Observational Model: Case Control
Time Perspective: Prospective
||A Feasibility Study For Monitoring And Recording Gastrointestinal Myoelectric Activity In Subjects With Suspected Or Diagnosed Irritable Bowel Syndrome (Lbs) And Reports Of GI Pain And Asymptomatic Subjects Without Lbs And GI Pain
Primary Outcome Measures:
- Device Success defined as the ability to record myoelectric signals in study subjects. [ Time Frame: Procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
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].
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Irritable bowel syndrome, functional bowel disorder.
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.
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
|Palo Alto, California, United States, 94303 |
|Contact: Steve Axelrod, PhD 650-269-1479 email@example.com |
|Principal Investigator: Steve Axelrod, PhD |
Eminence Clinical Research, Inc.
||Prince Shah, MD
||G-Tech Chief Medical Officer and Medical Monitor
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2012
||March 12, 2015
||United States: Institutional Review Board
Keywords provided by G-Tech Corporation:
Irritable bowel syndrome
Gastrointestinal functional disorder
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 25, 2015
Digestive System Diseases
Irritable Bowel Syndrome
Colonic Diseases, Functional