G-Tech to launch a clinical study with the "GutCheck" patch system
Mountain View, CA, February 15, 2016
G-Tech is launching a feasibility study, “Measurement of Gastrointestinal Myoelectric Activity in Patients At Risk For or Who Have a Post-Operative Ileus” using the GutCheck System, comprised of wireless, wearable, disposable patches and an app, to measure the electrical activity from the stomach, small intestine and colon. The study will retrospectively look for differences in the patterns of patients who develop an ileus (also called an intestinal pseudo-obstruction) and patients who have normal return of GI activity following surgery that could be used to predict who might develop ileus.
“Post-op ileus is a common problem following abdominal surgery that can cause abdominal pain, nausea, vomiting and other morbidities in patients. It extends their hospital stays and adds thousands of dollars of cost to their care, while increasing the risk of readmission,” said Steve Axelrod, PhD, President and CEO of G-Tech Medical. “The GutCheck system's ability to monitor stomach and intestinal motor activity continuously and non-invasively could help physicians detect the onset of ileus at an early stage and help minimize these highly undesirable effects.”
El Camino Hospital will be the first site to trial the GutCheck System by G-Tech Medical. The two-year trial is expected to enroll 80 study participants at El Camino Hospital. Participation in the trial is open to adult patients who undergo an open or laparoscopic GI surgery. During the participant’s hospital stay, a GutCheck patch will be placed on the patient’s abdominal skin to measure the natural electrical activity in the GI tract following surgery. The electrical activity will be transmitted to a mobile device and cloud server for frequency analysis.
Insights from G-Tech's proof of concept clinical study with wired, EKG style hardware
Palo Alto, CA, January 1, 2014
G-Tech conducted an IRB approved clinical trial as 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 total of 102 tests were conducted with both controls and patients referred by partner gastroenterologists. The test used traditional wired EKG style hardware, essentially 3 EKG systems in parallel, with 30 electrodes in a grid across the abdomen. Data was acquired for a 3 hour period while the patient reclined on a comfortable chair. They began having fasted for at least 4 hours and were fed a standardized 700 kCal meal 60 minutes into the test.
The raw data was recorded and digitized from each of the 18 sense electrodes for later analysis by a custom LabVIEW based application. In the course of the study algorithms that identified the instances of rhythmic electrical activity associated with mixing and propulsion of the luminal contents of the stomach, small intestine and colon were developed.Although the signals measured are very small, in the range of tens to hundreds of microvolts, the rhythmic patterns are quite clear when transformed into frequency space seen in the profiles for two subjects below which show normal and dysrythmic behaviour.
The figure on the left shows a frequency profile (top) for a control subject with its corresponding intensity (bottom) with a clear uptake at meal intake. One can also observe the drop in the stomach frequency from 3.3 to 2.8 at the time of the meal. This phenomenon is called the accomodation reflex where the stomach relaxes to allow for the meal. However, in the figure on the right this behaviour is absent and is replaced with dysrythmia in both the frequency and intensity space suggesting delayed gastric empyting.
Proprietary algorithms were developed that characterize and calculate activity profiles for each of these individual organs. The figure below shows examples of patients with varying symptoms and their corresponding individual organ activity profiles.
These results based on just 3 hours of recording give a unique glimpse into the inner workings of the GI tract of these patients.
The G-Tech "GutCheck" Patch will be worn by the individuals at a minimum of 3 days (72 hours) and will record all three major organs (stomach, small intestine and colon) over several full days (good and bad days) minute by minute, hour by hour through different stresses, different foods and symptoms. Big data algorithms will create each person’s unique internal GI signature based on their responses to specific meals, medications and patterns leading to and during symptoms (pain, cramps, nausea, bloating). The comprehensiveness and statistical thoroughness of the information will isolate and pinpoint the issues and potentially revolutionize the diagnosis and treatment of functional digestive disorders.
Data from this trial has been presented at the American College of Gastroenterology's 79th Annual Scientific Meeting in October 2014. More recently, two additional abstracts have been accepted to be presented at the Digestive Disease Week in May 2016.
- Signal Acquisition and Analysis of Surface-Measured Myoelectrical Signals of the Human GI tract. Triadafilopoulos G, Axelrod S, Navalgund A, Shah P, Devanaboyina U. ACG 2014 Annual Scientific Meeting and Postgraduate Course. Philadelphia, Pennsylvania Oct 2014
- Signal Processing and Preliminary Clinical Utility of Surface-Measured Myoelectrical Signals of the Human GI tract. Triadafilopoulos G, Axelrod S, Navalgund A, Shah P, Devanaboyina U. ACG 2014 Annual Scientific Meeting and Postgraduate Course. Philadelphia, Pennsylvania Oct 2014
- Early Clinical Utility of Surface-Measured Myoelectrical Signals of the Human GI tract. Triadafilopoulos G, Axelrod S, Navalgund A, Shah P, Devanaboyina U. ACG 2014 Annual Scientific Meeting and Postgraduate Course. Philadelphia, Pennsylvania Oct 2014
- Distinctive Electrical Signal Patterns Recorded at the Abdominal Surface in Subjects With Gastroparesis and Gastroesophageal Reflux Disease. Navalgund A, Kafai N, Axelrod S and Triadafilopoulos G. Digestive Disease Week 2016, San Diego, CA
- Spatial Localization of Surface-Measured Rhythmic Myoelectric Signals From Stomach, Small Intestine and Colon. Axelrod L, Navalgund A, Axelrod S and Triadafilopoulos G, Digestive Disease Week 2016, San Diego, CA
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