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

Recruiting

• Conditions: Post-operative Ileus
• Interventions: Device: G-Tech Myoelectric recording device

• 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

Arm && Interventions

Group	Intervention	Description
Subjects with unknown POI status consented pre-surgery	G-Tech Myoelectric recording device	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.
Subjects with known/unknown POI status consented post-surgery	G-Tech Myoelectric recording device	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.

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