G-Tech Feasibility Study for Early Detection of a Post-op Ileus

Study Overview
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Brief Summary
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This feasibility study is for the purpose of determining if the G-Tech Device can differentiate between normal return of GI activity post-operatively and the myoelectric activity in patients who develop a POI.

Detailed Description
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While preventing the development of a POI is most important, POIs still occur; therefore, it is important to definitively diagnose a POI as early as possible during the post-operative course for treatment to prevent patient discomfort, complications, and extended hospital stay. The purpose of the G-Tech study is to determine if the G-Tech Device can detect a difference in the myoelectric signals from patients who develop a POI compared to those patients who do not develop a POI. It is anticipated that up to 20% of patients enrolled in this study and consented preoperatively, excluding screen failures, will show evidence of a post-operative ileus as detected by the G-Tech GutCheck Device and differentiate the myoelectric signals from the patients who do not develop a POI. Patients who are known to have developed a POI may also be selected for the study.

Official Title
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Measurement Of GI Myoelectric Activity In Patients At Risk For Or Who Have A Post-Operative Ileus (POI) - Monitoring/ Recording GI Myoelectric Activity For Early Detection of A POI

Conditions
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Post-operative Ileus

Intervention / Treatment
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* Device: G-Tech Myoelectric recording device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide informed consent; Eighteen (18) years of age or older; Subject is willing and able to follow all study requirements; Subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity. Exclusion Criteria: Subject is pregnant or suspects pregnancy; Known allergy to medical grade adhesive; Weight > 350 lbs (159 Kg);

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with unknown POI status consented pre-surgery<br>Up to 100 subjects may be consented prior to surgery who are planned to undergo gastrointestinal surgery or a planned surgery that does not involve the abdominal cavity. The investigator does not change the routine medical care of study participants. | Device: G-Tech Myoelectric recording device<br>* A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.<br>* Other names: Gastro-intestinal electrical recording;|
| Subjects with known/unknown POI status consented post-surgery<br>Up to 50 subjects who have undergone gastrointestinal surgery or surgery not involving the abdominal cavity may be consented post- operatively during their hospital stay for this study.The investigator does not change the routine medical care of study participants. | Device: G-Tech Myoelectric recording device<br>* A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.<br>* Other names: Gastro-intestinal electrical recording;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoelectric activity pattern in POI patients versus non-POI patients | The resumption of motor activity in the stomach, small intestine, and colon post-operatively. The measurement is myoelectric signals measured at the skin surface similar to ECG recordings for the heart | Up to 6 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated Adverse Events | Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch. | Up to 6 days | 
| UADEs | Unanticipated adverse device effects | Up to 6 Days | 
| Device Success | Device success defined as the ability to record GI myoelectric activity following GI surgery. | Up to 6 Days |