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| Name | Class |
|---|---|
| Eminence Clinical Research, Inc. | INDUSTRY |
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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.
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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recording of Myoelectric Signals | Device | Obtain recordings of the electrical signals of the gut. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 hours at time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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General Eligibility Criteria:
General Inclusion Criteria
General Exclusion Criteria
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.
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Irritable bowel syndrome, functional bowel disorder.
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| Name | Affiliation | Role |
|---|---|---|
| Prince Shah, MD | G-Tech Chief Medical Officer and Medical Monitor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G-Tech Corporation | Mountain View | California | 94040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Triadafilopoulos, George, et al. |
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Present in abstracts at society meetings and enter on-line on this website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Device Arm | 88 individuals were studied. Of the 88 individuals, 77 with FGID symptoms (constipation, diarrhea, pain, bloating) and 11 nominally healthy controls were studied. Data from the subjects were normalized to allow quantitative comparisons. Peaks in the frequency spectrum presumably due to motor activity were algorithmically identified and their total volume calculated. This was performed for the pre-prandial hour, a post-prandial 40-minute period and the final hour. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 88 individuals met the eligibility criteria as described in the previous section and received the investigational device
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Device Arm | 88 individuals participated in this study. Data from all the subjects were normalized to allow quantitative comparisons. Peaks in the frequency spectrum presumably due to motor activity were algorithmically identified and their total volume calculated. This was performed for the pre-prandial hour, a post-prandial 40-minute period and the final hour. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. 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. | Posted | Number | participants | Up to 4 hours at time of procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational Device Arm | 77 patients with FGID symptoms (constipation, diarrhea, pain, bloating) and 11 nominally healthy controls were tested. Data from different subjects were normalized to allow quantitative comparisons. Peaks in the frequency spectrum presumably due to motor activity were algorithmically identified and their total volume calculated. This was performed for the pre-prandial hour, a post-prandial 40-minute period and the final hour. |
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This 3 hour clinical trial was carried out as an investigation to determine the viability of a wireless, waterproof patch based system. 3 days of data would provide full coverage of all GI events, and nearly 5x the statistical precision of this test.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Axelrod, PhD, CEO | G-Tech Medical | 650-269-1479 | steve.axelrod@gtechhealth.com |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Number of Participants with FGID symptoms and those who denied having FGID symptoms | Count of Participants | Participants |
|
| OG000 |
| Investigational Device Arm |
88 individuals in all were studied. 77 individuals reported having FGID symptoms (constipation, diarrhea, pain, bloating) and 11 individuals denied having any FGID symptoms. Data from all subjects were normalized to allow quantitative comparisons. Peaks in the frequency spectrum linked to gastrointestinal motor activity were algorithmically identified and their total volume calculated. This was performed for the pre-prandial hour, a post-prandial 40-minute period and the final hour. |
|
|
| 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. | Among the subjects studied, a sub group of subjects reported having gastroparesis and reflux disorders. These subjects were analyzed as separate groups and compared to the subjects who denied having any gastrointestinal disorders. | Posted | Mean | Standard Deviation | (mV)^2 x Hz | Up to 4 hours at time of procedure |
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|
|
| 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 | Posted | Number | adverse events | Up to 4 hours at time of procedure |
|
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| 0 |
| 88 |
| 0 |
| 88 |
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| Stomach Postprandial myoelectrical activity 1st hr |
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| Stomach Postprandial myoelectrical activity 2nd hr |
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| Intestine Preprandial myoelectrical activity |
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| Intestine Postprandial myoelectrical activity 1st hr |
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| Intestine Postprandial myoelectrical activity 2nd hr |
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| Colon Preprandial myoelectrical activity |
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| Colon Postprandial myoelectrical activity 1st hr |
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| Colon Postprandial myoelectrical activity 2nd hr |
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