Mountain View, California 94040

  • operative Ileus

Purpose:

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.


Study summary:

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.


Criteria:

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); 4. Has undergone a prior vagotomy; 5. Subject has an implanted medical devices such as a pacemaker, medication pump, neurostimulator, or gastric stimulator.


NCT ID:

NCT02673671


Primary Contact:

Principal Investigator
George Triadafilopoulos, MD
El Camino GI Medical Associates

Steve Axelrod, PhD
Phone: 650-269-1479
Email: steve.axelrod@gtechhealth.com


Backup Contact:

N/A


Location Contact:

Mountain View, California 94040
United States

Steve Axelrod, PhD
Phone: 650-269-1479
Email: steve.axelrod@gtechhealth.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 17, 2021

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