Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
Condition(s) studied
Investigational drug(s) / intervention(s)
xBar™ System: Device: The xBar™ device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols Description: The Exero Medical xBar™ System is designed to provide continuous postoperative monitoring of gastrointestinal (GI) anastomoses to support the early identification of anastomotic leaks. The device functions by integrating a sensing electrode array into a standard surgical drain, thereby enabling monitoring without altering standard surgical protocols.
Study summary
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Eligibility
Primary outcome measure(s)
- Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts — At the time points of 30 and 90 days following index surgery
Non-inferiority of the mean Modified Comprehensive Complication Index (MCCI) of the modified intent-to-treat (mITT) population at 30 days following the index surgery, compared with the MCCI of the matched historical cohort. - Primary Safety Endpoint - No Unexpected Serious Adverse Device Events within the Intent to Treat population during the study period ( up to 365 days following index surgery) — from the date of index surgery up to 365 days following the index surgery
Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period ( up to 365 days from the index surgery)
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Louisville Hospital | Louisville | Kentucky | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | Recruiting |
| Bryan Medical Center | Lincoln | Nebraska | Recruiting |
| Weill Cornell Medicine Colon and Rectal Surgery | New York | New York | Recruiting |
| Department of Colon and Rectal Surgery | New York | New York | Not Yet Recruiting |
| Allegheny Health Network | Pittsburgh | Pennsylvania | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07337590 on ClinicalTrials.gov ↗ ← All trials in the USA