Status:
RECRUITING
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Lead Sponsor:
Exero Medical Ltd.
Conditions:
Colorectal Surgery
Anastomotic Leak
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 clin...
Detailed Description
Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, ...
Eligibility Criteria
Inclusion
- Age ≥ 22 years
- Indication for sigmoid or rectal resection surgery.
- Usage of drain during the surgery (to be confirmed during the surgery)
- Willing and able to comply with the study follow up.
- Able and agree to provide an informed consent.
Exclusion
- Contraindication for surgery and/or general anesthesia.
- Pregnancy or lactation.
- Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
- Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
- Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
- Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
- Participation in another interventional study during the xBar system usage.
Key Trial Info
Start Date :
March 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06168669
Start Date
March 11 2023
End Date
December 1 2025
Last Update
September 30 2025
Active Locations (13)
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1
AdventHealth Orlando
Orlando, Florida, United States, 328803
2
AdventHealth Tampa
Tampa, Florida, United States, 33613
3
University of Louisville
Louisville, Kentucky, United States, 40202
4
Henry Ford Health
Detroit, Michigan, United States, 48202