Completed
Phase Not Applicable
Age: 22Years +
All Genders
ID06168669
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Led by Exero Medical Ltd. · Updated on 2026-06-26
222
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Who Can Participate
Age: 22Years +
All Genders
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
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