Gastrointestinal Diseases
Conditions
Keywords
Irritable bowel syndrome, IBS, Gastrointestinal pain, Gastrointestinal functional 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 \[subjects without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain\].
Interventions
DEVICERecording of Myoelectric Signals
Obtain recordings of the electrical signals of the gut.
Sponsors
Eminence Clinical Research, Inc.
G-Tech Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Outcome | Up to 4 hours at time of procedure | 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. |
| Number of Anticipated, Un-Anticipated, and Serious Adverse Events | Up to 4 hours at time of procedure | Assess and record anticipated adverse events (AEs), unanticipated adverse device effects (UADEs), and serious adverse events (SAEs) at time of recording |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 88 |
| Total | 88 |
Baseline characteristics
| Characteristic | Investigational Device Arm |
|---|---|
| Age, Continuous | 48.9 years |
| Number of Participants with FGID symptoms and those who denied having FGID symptoms FGID symptoms absent (healthy controls) | 11 Participants |
| Number of Participants with FGID symptoms and those who denied having FGID symptoms FGID Symptoms present | 77 Participants |
| Race/Ethnicity, Customized Race - Asian | 6 participants |
| Race/Ethnicity, Customized Race - Caucasian | 68 participants |
| Race/Ethnicity, Customized Race - Hispanic or Latino | 14 participants |
| Region of Enrollment United States | 88 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 88 |
| serious Total, serious adverse events | 0 / 88 |
Outcome results
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.
Time frame: Up to 4 hours at time of procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Device Arm | Device Success Defined as the Ability to Record Myoelectric Signals in Study Subjects. | 88 participants |
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
Time frame: Up to 4 hours at time of procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Device Arm | Number of Anticipated, Un-Anticipated, and Serious Adverse Events | 0 adverse events |
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.
Time frame: Up to 4 hours at time of procedure
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Device Arm | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 1st hr | 5.25 (mV)^2 x Hz | Standard Deviation 2.42 |
| Investigational Device Arm | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 2nd hr | 7.24 (mV)^2 x Hz | Standard Deviation 4.26 |
| Investigational Device Arm | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 2nd hr | 7.39 (mV)^2 x Hz | Standard Deviation 8 |
| Investigational Device Arm | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 2nd hr | 20.18 (mV)^2 x Hz | Standard Deviation 10.49 |
| Investigational Device Arm | Secondary Efficacy Outcome | Colon Preprandial myoelectrical activity | 3.32 (mV)^2 x Hz | Standard Deviation 3.81 |
| Investigational Device Arm | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 1st hr | 24.46 (mV)^2 x Hz | Standard Deviation 11.55 |
| Investigational Device Arm | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 1st hr | 4.75 (mV)^2 x Hz | Standard Deviation 2.82 |
| Investigational Device Arm | Secondary Efficacy Outcome | Stomach Preprandial myoelectrical activity | 2.14 (mV)^2 x Hz | Standard Deviation 1.27 |
| Investigational Device Arm | Secondary Efficacy Outcome | Intestine Preprandial myoelectrical activity | 16.27 (mV)^2 x Hz | Standard Deviation 15.16 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 2nd hr | 9.26 (mV)^2 x Hz | Standard Deviation 6.6 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 2nd hr | 10.03 (mV)^2 x Hz | Standard Deviation 8.54 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 1st hr | 1.54 (mV)^2 x Hz | Standard Deviation 0.86 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 2nd hr | 1.57 (mV)^2 x Hz | Standard Deviation 0.87 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Stomach Preprandial myoelectrical activity | 0.75 (mV)^2 x Hz | Standard Deviation 0.82 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 1st hr | 11.83 (mV)^2 x Hz | Standard Deviation 12.43 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Intestine Preprandial myoelectrical activity | 7.68 (mV)^2 x Hz | Standard Deviation 6.09 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Colon Preprandial myoelectrical activity | 4.39 (mV)^2 x Hz | Standard Deviation 4.05 |
| Individuals With Gastroparesis | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 1st hr | 9.38 (mV)^2 x Hz | Standard Deviation 5.94 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 1st hr | 5.16 (mV)^2 x Hz | Standard Deviation 4.9 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 2nd hr | 15.28 (mV)^2 x Hz | Standard Deviation 6.88 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Intestine Preprandial myoelectrical activity | 10.24 (mV)^2 x Hz | Standard Deviation 8.67 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 1st hr | 3.98 (mV)^2 x Hz | Standard Deviation 4.02 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 2nd hr | 3.81 (mV)^2 x Hz | Standard Deviation 2.8 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 2nd hr | 11.41 (mV)^2 x Hz | Standard Deviation 20.7 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Colon Preprandial myoelectrical activity | 8.60 (mV)^2 x Hz | Standard Deviation 14.54 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 1st hr | 16.36 (mV)^2 x Hz | Standard Deviation 8.78 |
| Individuals With Reflux Disorder | Secondary Efficacy Outcome | Stomach Preprandial myoelectrical activity | 0.78 (mV)^2 x Hz | Standard Deviation 0.61 |
| Individuals With Bloating | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 2nd hr | 20.76 (mV)^2 x Hz | Standard Deviation 11.42 |
| Individuals With Bloating | Secondary Efficacy Outcome | Stomach Preprandial myoelectrical activity | 1.24 (mV)^2 x Hz | Standard Deviation 1.56 |
| Individuals With Bloating | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 1st hr | 5.02 (mV)^2 x Hz | Standard Deviation 5.68 |
| Individuals With Bloating | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 2nd hr | 9.29 (mV)^2 x Hz | Standard Deviation 17.4 |
| Individuals With Bloating | Secondary Efficacy Outcome | Intestine Preprandial myoelectrical activity | 12.04 (mV)^2 x Hz | Standard Deviation 9.39 |
| Individuals With Bloating | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 1st hr | 24.01 (mV)^2 x Hz | Standard Deviation 15.06 |
| Individuals With Bloating | Secondary Efficacy Outcome | Colon Preprandial myoelectrical activity | 9.24 (mV)^2 x Hz | Standard Deviation 11.91 |
| Individuals With Bloating | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 1st hr | 4.49 (mV)^2 x Hz | Standard Deviation 2.76 |
| Individuals With Bloating | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 2nd hr | 8.20 (mV)^2 x Hz | Standard Deviation 4.84 |
| Individuals With Constipation | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 1st hr | 16.87 (mV)^2 x Hz | Standard Deviation 8.11 |
| Individuals With Constipation | Secondary Efficacy Outcome | Intestine Preprandial myoelectrical activity | 11.49 (mV)^2 x Hz | Standard Deviation 6.72 |
| Individuals With Constipation | Secondary Efficacy Outcome | Colon Preprandial myoelectrical activity | 7.50 (mV)^2 x Hz | Standard Deviation 8.98 |
| Individuals With Constipation | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 2nd hr | 7.19 (mV)^2 x Hz | Standard Deviation 5.75 |
| Individuals With Constipation | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 2nd hr | 8.28 (mV)^2 x Hz | Standard Deviation 9.28 |
| Individuals With Constipation | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 1st hr | 5.01 (mV)^2 x Hz | Standard Deviation 6.24 |
| Individuals With Constipation | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 1st hr | 8.62 (mV)^2 x Hz | Standard Deviation 15.67 |
| Individuals With Constipation | Secondary Efficacy Outcome | Stomach Preprandial myoelectrical activity | 1.89 (mV)^2 x Hz | Standard Deviation 1.88 |
| Individuals With Constipation | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 2nd hr | 14.33 (mV)^2 x Hz | Standard Deviation 7.42 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Stomach Preprandial myoelectrical activity | 1.61 (mV)^2 x Hz | Standard Deviation 1.62 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Intestine Preprandial myoelectrical activity | 14.55 (mV)^2 x Hz | Standard Deviation 9.94 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 2nd hr | 19.17 (mV)^2 x Hz | Standard Deviation 15.49 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 2nd hr | 7.39 (mV)^2 x Hz | Standard Deviation 9.07 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Colon Postprandial myoelectrical activity 1st hr | 10.68 (mV)^2 x Hz | Standard Deviation 13.78 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Colon Preprandial myoelectrical activity | 6.43 (mV)^2 x Hz | Standard Deviation 7.25 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 2nd hr | 3.91 (mV)^2 x Hz | Standard Deviation 3.06 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Intestine Postprandial myoelectrical activity 1st hr | 21.79 (mV)^2 x Hz | Standard Deviation 14.8 |
| Individuals With Diarrhea | Secondary Efficacy Outcome | Stomach Postprandial myoelectrical activity 1st hr | 3.53 (mV)^2 x Hz | Standard Deviation 2.79 |