Recruiting

Observational Study

Sponsor:

G-Tech Corporation

Code:

NCT05712525

Conditions

Gastrointestinal Diseases

Ileus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

G-Tech Wireless Patch System (WPS)

Study Details

Brief summary:

The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them..

Conditions

Gastrointestinal Diseases

Ileus

Study ID

NCT05712525

Start date

Oct 7, 2022

Status verified date

Jan, 2023

Completion date

Oct 6, 2024

Anticipated

Primary completion date

Oct 6, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willing and able to follow all study requirements
  • Eighteen (18) years of age or older
  • Subject is willing and able to follow all study requirements
  • Subject will undergo a colectomy

Exclusion Criteria:

  • Subject is pregnant or suspects pregnancy
  • Known allergy to medical grade adhesive

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

G-Tech Wireless Patch System (WPS)

Noninvasive monitoring of myoelectrical signals

Primary outcome measure

  • GI Functional Recovery [ Time Frame: 30 days after surgery ]

Central Contacts and Locations

Central contacts

Robert C Kirby, BS, MBA

9497517704rob@gtechmedical.com

Steve Axelrod, Ph D

6502691479steve.axelrod@gtechhealth.com

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Anna George, MS

617-632-7031ageorge5@bidmc.harvard.edu

More Information

Sponsor

G-Tech Corporation

Last update posted

Feb 3, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by G-Tech Corporation on 2023-02-03.