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

G-Tech Corporation

Status: Enrolling

Conditions: Post-operative Ileus

Treatments: Device: G-Tech Myoelectric recording device

Study type: Observational

Funder types: Industry

Identifiers

NCT02673671

CLP-2014-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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);

Trial design

150 participants in 2 patient groups

Subjects with unknown POI status consented pre-surgery

Description:

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.

Treatment:

Device: G-Tech Myoelectric recording device

Subjects with known/unknown POI status consented post-surgery

Description:

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.

Treatment:

Device: G-Tech Myoelectric recording device