Gastrointestinal DiseasesNCT01697397
Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol
An observational study of Gastrointestinal Diseases, run by G-Tech Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Recording of Myoelectric Signals
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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].
- Conditions
- Gastrointestinal Diseases
- Being tested
- Recording of Myoelectric Signals
- Keywords
- Irritable bowel syndrome, IBS, Gastrointestinal pain, Gastrointestinal functional disorder
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of Myoelectric SignalsDevice
Obtain recordings of the electrical signals of the gut.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Recording of Myoelectric Signals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 hours at time of procedure
Secondary outcomes (2)
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.
Measured: Up to 4 hours at time of procedure
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
Measured: Up to 4 hours at time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- G-Tech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eminence Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Prince Shah, MD, Study chair, G-Tech Chief Medical Officer and Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697397
- Sponsor's protocol ID
- CLP-2012-001
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2012
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Present in abstracts at society meetings and enter on-line on this website.
Publications
Triadafilopoulos, George, et al.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01697397
- Acronym / sponsor ID
- CLP-2012-001
- Conditions
- Gastrointestinal Diseases
- Keywords
- Irritable bowel syndrome, IBS, Gastrointestinal pain, Gastrointestinal functional disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- G-Tech CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Eminence Clinical Research, Inc.
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Posted 23 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with and without FGIDs/IBS | – | Device: Recording of Myoelectric SignalsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Irritable bowel syndrome, functional bowel disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of Myoelectric SignalsObtain recordings of the electrical signals of the gut. | Device | Patients with and without FGIDs/IBS |
Primary outcome
Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects.
Time frame: Up to 4 hours at time of procedure
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.
2 secondary outcomes
Secondary Efficacy Outcome
Time frame: Up to 4 hours at time of procedure
Number of Anticipated, Un-Anticipated, and Serious Adverse Events
Time frame: Up to 4 hours at time of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationTriadafilopoulos, George, et al.
- Individual participant dataSharing planned: Undecided. Present in abstracts at society meetings and enter on-line on this website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prince Shah, MD study chair
G-Tech Chief Medical Officer and Medical Monitor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases, run by G-Tech Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects. (time frame: Up to 4 hours at time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01697397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.