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

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

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 Overview

• Status: Recruiting
• Conditions: Post-operative Ileus
• Intervention / Treatment: Device: G-Tech Myoelectric recording device

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • Recruiting
      • El Camino Hospital
      • Contact: Anand Navalgund, PhD; Phone Number: 614-886-7789; Email: anand.navalgund@gtechhealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include candidates who undergo GI surgery or other surgery outside not involving the abdominal cavity, who agree to the application of the G-Tech Device to be placed on his/her abdomen and meet all eligibility criteria as defined. 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 or following. 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with unknown POI status consented pre-surgery; 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.	Device: G-Tech Myoelectric recording device; A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.; Other Names: Gastro-intestinal electrical recording
Subjects with known/unknown POI status consented post-surgery; 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.	Device: G-Tech Myoelectric recording device; A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.; Other Names: Gastro-intestinal electrical recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myoelectric activity pattern in POI patients versus non-POI patients	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	Up to 6 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anticipated Adverse Events	Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.	Up to 6 days
UADEs	Unanticipated adverse device effects	Up to 6 Days
Device Success	Device success defined as the ability to record GI myoelectric activity following GI surgery.	Up to 6 Days

Collaborators and Investigators

• Sponsor: G-Tech Corporation
• Collaborators: Eminence Clinical Research, Inc.
• Investigators: Principal Investigator: George Triadafilopoulos, MD, El Camino GI Medical Associates

Publications and helpful links

General Publications

• Bederman SS, Betsy M, Winiarsky R, Seldes RM, Sharrock NE, Sculco TP. Postoperative ileus in the lower extremity arthroplasty patient. J Arthroplasty. 2001 Dec;16(8):1066-70. doi: 10.1054/arth.2001.27675.
• Doorly MG, Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Surg Clin North Am. 2012 Apr;92(2):259-72, viii. doi: 10.1016/j.suc.2012.01.010.
• Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.
• Frantzides CT, Cowles V, Salaymeh B, Tekin E, Condon RE. Morphine effects on human colonic myoelectric activity in the postoperative period. Am J Surg. 1992 Jan;163(1):144-8; discussion 148-9. doi: 10.1016/0002-9610(92)90267-u.
• Tropskaya NS and Popova TS. (2012). Postoperative Ileus: Pathophysiology and Treatment in Current Concepts in Colonic Disorders, Dr. Godfrey Lule (Ed.), ISBN: 978-953-307-957-8, InTech, Available from: http://www.intechopen.com/books/current-concepts-in-colonic-disorders/postoperative-ileus-pathophysiologyand-treatment.
• Waldhausen JH, Shaffrey ME, Skenderis BS 2nd, Jones RS, Schirmer BD. Gastrointestinal myoelectric and clinical patterns of recovery after laparotomy. Ann Surg. 1990 Jun;211(6):777-84; discussion 785. doi: 10.1097/00000658-199006000-00018.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: CLP-2014-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Analyses planned to be presented at scientific meetings and published in peer reviewed medical journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No