Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
Start Date
3/10/2026
Completion Date
12/1/2027
Summary
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Detailed Description
The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in the intervention group admitted for low anterior resection surgery will have xBar placed during their index surgery. The overall morbidity, healthcare utilization costs, and stoma utilization of the intervention group will be compared to those of the historical control group, consisting of patients meeting the same inclusion/exclusion criteria of the patients in the intervention group. The xBar system, classified as a non-significant risk device in the pivotal study, is designed as an integrated platform for post-operative monitoring, built to fit into the existing clinical workflow without altering the standard surgical protocol.
Eligibility Criteria
Age Range: 21 years to No maximum
Interventions
xBar™ System
Conditions
Locations
University of Louisville Hospital
Louisville, Kentucky 40202
United States
Johns Hopkins University
Baltimore, Maryland 21287
United States
Bryan Medical Center
Lincoln, Nebraska 68506
United States
Weill Cornell Medicine Colon and Rectal Surgery
New York, New York 10021
United States
Department of Colon and Rectal Surgery
New York, New York 10075
United States
Allegheny Health Network
Pittsburgh, Pennsylvania 15212
United States