Post-operative Ileus
Conditions
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.
Interventions
DEVICEG-Tech Myoelectric recording device
A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.
Sponsors
Eminence Clinical Research, Inc.
G-Tech Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Anticipated Adverse Events | Up to 6 days | Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch. |
| UADEs | Up to 6 Days | Unanticipated adverse device effects |
| Device Success | Up to 6 Days | Device success defined as the ability to record GI myoelectric activity following GI surgery. |
Countries
United States
Contacts
Primary ContactSteve Axelrod, PhD
Outcome results
None listed