Gut Recovery In Patients Following Surgery

Recruiting

• Conditions: Ileus; Gastrointestinal Diseases

• Registration Number: NCT05712525
• Lead Sponsor: G-Tech Corporation

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..

Detailed 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.

Study Timeline

• Study Start: 2022-10-07
• Status Verified: 2023-01
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-01-25
• Last Update Submitted: 2023-01-25
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-03
• Primary Completion: 2023-10-06
• Study Completion: 2024-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GI Functional Recovery	30 days after surgery	Observe a correlation between signal strength and the rate of gastrointestinal recovery following surgery.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	30 days after surgery	Anticipated adverse events through hospitalization; Unanticipated adverse events (UADEs) through hospitalization

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States