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NCT05712525 Clinical Trial

Gut Recovery In Patients Following Surgery

Gastrointestinal Diseases Clinical Trial

— GRIPS  

Official title:
Gut Recovery In Patients Following Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05712525
Other study ID # CLP-2022-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 7, 2022
Est. completion date October 6, 2024

Study information
Verified date January 2023
Source G-Tech Corporation
Contact Robert C Kirby, BS, MBA
Phone 9497517704
Email rob@gtechmedical.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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..

Description:

Measure myoelectric signals with the G-Tech WPS and determine if a correlation exists between signal strength and the rate of gastrointestinal recovery following surgery. Determine the relationship between gastrointestinal myoelectrical signal strength and clinical markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date October 6, 2024
Est. primary completion date October 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• G-Tech Wireless Patch System (WPS)
Noninvasive monitoring of myoelectrical signals

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
G-Tech Corporation Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary GI Functional Recovery Observe a correlation between signal strength and the rate of gastrointestinal recovery following surgery. 30 days after surgery
Secondary Adverse Events Anticipated adverse events through hospitalization; Unanticipated adverse events (UADEs) through hospitalization 30 days after surgery
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