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

NCT02673671 | Unknown

• 1 other identifier: CLP-2014-001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Ileus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Anticipated Adverse Events

  Up to 6 days

• UADEs

  Up to 6 Days

• Device Success

  Up to 6 Days

Study Arms (2)

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

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

Interventions

G-Tech Myoelectric recording device DEVICE

A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.

Also known as: Gastro-intestinal electrical recording

Subjects with known/unknown POI status consented post-surgery; Subjects with unknown POI status consented pre-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Willing and able to provide informed consent;
• Eighteen (18) years of age or older;
• Subject is willing and able to follow all study requirements;
• Subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity.

You may not qualify if:

• Subject is pregnant or suspects pregnancy;
• Known allergy to medical grade adhesive;
• Weight \> 350 lbs (159 Kg);

Sponsors & Collaborators

• G-Tech Corporation: lead
• Eminence Clinical Research, Inc.: collaborator

Study Sites (1)

El Camino Hospital

Mountain View, California, 94040, United States

RECRUITING

Related 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.

  PMID: 11740765 BACKGROUND

• 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.

  PMID: 22414412 BACKGROUND

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

  PMID: 15017498 BACKGROUND

• 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.

  PMID: 1733363 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 2357140 BACKGROUND

Study Officials

• George Triadafilopoulos, MD

  El Camino GI Medical Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve Axelrod, PhD

CONTACT

650-269-1479; steve.axelrod@gtechhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)