Measurement of Gastrointestinal Myoelectric Activity in Patients at Risk for or Who Have a Post-Operative Ileus (POI)

Phase: Pilot/Feasibility
Status: Recruiting

The purpose of this study is to record the electrical signals that naturally occur in the digestive tract (also called the gastrointestinal or GI tract) and motility patterns in individuals who undergo surgery. Patients who have GI surgery have the potential to develop an ileus after surgery. An ileus is a condition that causes the intestinal contents to back up because peristalsis (the forward movement of contents) fails, although the inside of the stomach and intestines do not have an obstruction. This study will test a device which measures the electrical activity from the GI tract and uses medical grade adhesive to adhere to the skin and which is placed on the stomach or abdomen to measure the natural electrical activity in the GI tract following surgery. Myoelectric activity is the electrical current that the smooth muscle cells in the GI tract generate. Like the electrocardiogram (ECG) of the heart, a signal of the activity can be detected at the skin surface. The purpose of the study is to measure the electrical activity in patients who develop an ileus and in patients who have normal return of GI activity following surgery to retrospectively look for differences in the patterns that could be used to predict who might develop ileus.

The Journal of Gastrointestinal Surgery recently published an article sharing the results following the completion of the first round of clinical trials using the GutCheck System by G-Tech Medical with patients at El Camino Hospital. The GutCheck System records the electrical signals that naturally occur in the digestive tract and patterns of intestinal contractions and movements in individuals who undergo surgery. The interim results showed that non-invasive measurement of colon activity after abdominal surgery was feasible and interventions could be optimized as a result of the information obtained by the device. El Camino Hospital was the first site to study the GutCheck System and ultimately, this information may help improve patient outcomes, decrease length of stay and lower costs.

If you are interested in learning more details, the published article can be found here.

 

Principal Investigator

George Triadafilopoulos, MD

 

Sponsor

G-Tech Medical, Inc.

NCT Number

NCT02673671

Contact

Kara Turner, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4562
Kara_Turner@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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