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

Post-operative Ileus Clinical Trial

— GTECHPOI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02673671
• Other study ID #: CLP-2014-001
• Status: Recruiting
• Start date: February 2016
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: G-Tech Corporation
• Contact: Steve Axelrod, PhD
• Phone: 650-269-1479
• Email: steve.axelrod[@]gtechhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Ileus
• Post-operative Ileus

Intervention

Device:
• G-Tech Myoelectric recording device
A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.

Locations

Country	Name	City	State
United States	El Camino Hospital	Mountain View	California

Sponsors (2)

Lead Sponsor	Collaborator
G-Tech Corporation	Eminence Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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