El Camino Hospital is pleased to announce it is a site for a medical device trial of the GutCheck System by G-Tech Medical, which records the electrical signals that naturally occur in the digestive tract (also called the gastrointestinal or GI tract) and patterns of intestinal contractions and movements in individuals who undergo surgery.
El Camino Hospital Launches GutCheck System clinical trial to measure electrical signals after surgery.
The pilot/feasibility study "Measurement of Gastrointestinal Myoelectric Activity in Patients At Risk For or Who Have a Post-Operative Ileus" uses the GutCheck System, comprised of a wireless, wearable, disposable patch and 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.
El Camino Hospital will be the first site to study the GutCheck System by G-Tech Medical, a company in residence at the Fogarty Institute for Innovation located on the hospital’s campus. 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 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.
"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.
"If proven effective, 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."
The National Institutes of Health estimates between 60 and 70 million Americans experience diseases that affect the digestive system. Functional Gastrointestinal Disorders (FGID) constitute a majority of all GI problems, which lead to over 40 million office visits annually.
Although they are not life threatening, FGIDs often greatly impact the lives of those afflicted and cannot be diagnosed with existing tests like colonoscopy, CT scans or other imaging. The GutCheck System hopes to analyze the electrical activity frequencies of the digestive organs under normal conditions to help pinpoint the source and nature of dysfunction to help physicians better target therapies and provide faster relief and at a lower cost for patients.
"The testing of the GutCheck System at El Camino Hospital showcases our leadership in innovative care and provides our patients with the latest options in digestive care," said George Triadafilopoulos, MD, principal investigator for GutCheck System trial at El Camino Hospital. "We continuously seek new devices and procedures to help us provide leading-edge, personalized care for our patients."
El Camino Hospital is an acute-care, 443-bed, nonprofit and locally governed organization with campuses in Mountain View and Los Gatos, California. Key medical specialties include cancer, heart and vascular, men’s health, mental health, neuroscience, orthopedic and spine, senior health, urology, and the first Women’s Hospital in Northern California.
G-Tech Medical, Inc. is an early-stage medical device company developing a low-cost, non-invasive, diagnostic solution for patients with gastrointestinal motility issues. G-Tech’s wearable patch-based "EKG for the Gut" will initially be used to monitor the return to function of the stomach, small intestine and colon following surgery.