NCT07337590

Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Exero Medical Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-03-10
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-01-13
• Last updated: 2026-04-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study