Gut Recovery In Patients Following Surgery | NCT05712525

Studies
Gut Recovery In Patients Following Surgery

NCT05712525

Sponsor

G-Tech Corporation

Status

Unknown status

Last Update Posted

Feb 3, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Gastrointestinal Diseases
Ileus

Interventions

G-Tech Wireless Patch System (WPS)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2022Actual

Primary Completion Date

Oct 6, 2023Estimated

Completion Date

Oct 6, 2024Estimated

First Submitted Date

Jan 25, 2023

First Submission Date that Met QC Criteria

Jan 25, 2023

First Posted Date

Feb 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2023

Last Update Posted Date

Feb 3, 2023Actual

Name	Class
Beth Israel Deaconess Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G-Tech Wireless Patch System (WPS)	Diagnostic Test	Noninvasive monitoring of myoelectrical signals

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	Anticipated adverse events through hospitalization; Unanticipated adverse events (UADEs) through hospitalization	30 days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who will undergo a colectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert C Kirby, BS, MBA	Contact	9497517704		rob@gtechmedical.com
Steve Axelrod, Ph D	Contact	6502691479		steve.axelrod@gtechhealth.com

Overall Officials

Name	Affiliation	Role
Kristen Crowell, MD	Beth Israel Deaconess Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center	Recruiting	Boston	Massachusetts	02215	United States

Condition Browse Module

MeSH Terms

ID	Term
D005767	Gastrointestinal Diseases
D045823	Ileus

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D007415	Intestinal Obstruction
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided