NCT05712525

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..

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2024

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 25, 2023

Last Update Submit

January 25, 2023

Conditions

Gastrointestinal DiseasesIleus

Outcome Measures

Primary Outcomes (1)

  • GI Functional Recovery

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

    30 days after surgery

Secondary Outcomes (1)

  • Adverse Events

    30 days after surgery

Interventions

G-Tech Wireless Patch System (WPS)DIAGNOSTIC_TEST

Noninvasive monitoring of myoelectrical signals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will undergo a colectomy

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal DiseasesIleus

Condition Hierarchy (Ancestors)

Digestive System DiseasesIntestinal ObstructionIntestinal Diseases

Study Officials

  • Kristen Crowell, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert C Kirby, BS, MBA

CONTACT

9497517704rob@gtechmedical.com

Steve Axelrod, Ph D

CONTACT

6502691479steve.axelrod@gtechhealth.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 3, 2023

Study Start

October 7, 2022

Primary Completion

October 6, 2023

Study Completion

October 6, 2024

Last Updated

February 3, 2023

Record last verified: 2023-01

Locations

US(1)