NCT02673671

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: G-Tech Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-operative Ileus

Interventions

Type	Name	Description
DEVICE	G-Tech Myoelectric recording device	A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.

Timeline

• Start date: 2016-02-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2016-02-04
• Last updated: 2023-01-20

Locations

1 site across 1 country: United States