Gut Recovery In Patients Following Surgery

NCT ID: NCT05712525

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-07

Study Completion Date

2024-10-06

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Diseases Ileus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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G-Tech Wireless Patch System (WPS)

Noninvasive monitoring of myoelectrical signals

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

G-Tech Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristen Crowell, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robert C Kirby, BS, MBA

Role: CONTACT

9497517704

Steve Axelrod, Ph D

Role: CONTACT

6502691479

Facility Contacts

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Anna George, MS

Role: primary

617-632-7031

Other Identifiers

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CLP-2022-001

Identifier Type: -

Identifier Source: org_study_id

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