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A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Sponsor: Exero Medical Ltd.
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
Conditions
Interventions
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