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RECRUITING
NCT06168669
NA

A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

Sponsor: Exero Medical Ltd.

View on ClinicalTrials.gov

Summary

Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system.

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2023-03-11

Completion Date

2025-12-01

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

xBar system

xBar system is surgical drain with embedded sensors. Collected data will be evaluated for an ability to identify anastomotic leaks. The xBar system does not have therapeutic indication.

Locations (13)

AdventHealth Orlando

Orlando, Florida, United States

AdventHealth Tampa

Tampa, Florida, United States

University of Louisville

Louisville, Kentucky, United States

Henry Ford Health

Detroit, Michigan, United States

Bryan Medical Center

Lincoln, Nebraska, United States

Weill Cornell MC, NY

New York, New York, United States

Mount Sinai Health System

New York, New York, United States

Northwell Health, NY

New York, New York, United States

Stony Brook University Hospital and Cancer Center

New York, New York, United States

HCA

Houston, Texas, United States

Soroka MC

Beersheba, Israel

Rabin MC

Petah Tikva, Israel

Kaplan MC

Rehovot, Israel