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GRIPS: Gut Recovery In Patients Following Surgery

Sponsor
G-Tech Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05712525
Collaborator
Beth Israel Deaconess Medical Center (Other)
150
Enrollment
1
Location
24
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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..

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: G-Tech Wireless Patch System (WPS)

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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Gut Recovery In Patients Following Surgery
Actual Study Start Date :
Oct 7, 2022
Anticipated Primary Completion Date :
Oct 6, 2023
Anticipated Study Completion Date :
Oct 6, 2024

Outcome Measures

Primary Outcome Measures

  1. GI Functional Recovery [30 days after surgery]

    Observe a correlation between signal strength and the rate of gastrointestinal recovery following surgery.

Secondary Outcome Measures

  1. Adverse Events [30 days after surgery]

    Anticipated adverse events through hospitalization; Unanticipated adverse events (UADEs) through hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

Sponsors and Collaborators

  • G-Tech Corporation
  • Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Kristen Crowell, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
G-Tech Corporation
ClinicalTrials.gov Identifier:
NCT05712525
Other Study ID Numbers:
  • CLP-2022-001
First Posted:
Feb 3, 2023
Last Update Posted:
Feb 3, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

Study Results

No Results Posted as of Feb 3, 2023