A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Completed · Not applicable
Conditions studied: Colorectal Surgery, Anastomotic Leak
In brief
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.
Key facts
- Study ID
- NCT06168669
- Run by
- Exero Medical Ltd.
- People needed
- 222
- Starts
- 2023-03-11
- Expected to finish
- 2025-09-29
- Last updated by the study team
- 2026-06-26
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- AdventHealth Orlando — Orlando, Florida, United States
- AdventHealth Tampa — Tampa, Florida, United States
- University of Louisville — Louisville, Kentucky, United States
- Henry Ford Health — Detroit, Michigan, United States
- Bryan Medical Center — Lincoln, Nebraska, United States
- Weill Cornell MC, NY — New York, New York, United States
- Mount Sinai Health System — New York, New York, United States
- Northwell Health, NY — New York, New York, United States
- Stony Brook University Hospital and Cancer Center — New York, New York, United States
- HCA — Houston, Texas, United States
- Soroka MC — Beersheba, Israel
- Rabin MC — Petah Tikva, Israel
- Kaplan MC — Rehovot, Israel
Full record on ClinicalTrials.gov
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