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

Recruiting

• Conditions: Post-operative Ileus

• Registration Number: NCT02673671
• Lead Sponsor: G-Tech Corporation

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-01-27
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-20
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Willing and able to provide informed consent;
2. Eighteen (18) years of age or older;
3. Subject is willing and able to follow all study requirements;
4. Subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity.

Exclusion Criteria

1. Subject is pregnant or suspects pregnancy;
2. Known allergy to medical grade adhesive;
3. Weight > 350 lbs (159 Kg);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myoelectric activity pattern in POI patients versus non-POI patients	Up to 6 Days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

El Camino Hospital; 🇺🇸 Mountain View, California, United States