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

NCT06168669 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • Colorectal Surgery
  • Anastomotic Leak

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.

Sponsors & Collaborators

  • Exero Medical Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-11
Primary Completion
2025-12-01
Completion
2025-12-01
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168669 on ClinicalTrials.gov