RecruitingNot ApplicableNCT06168669
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Sponsor
Exero Medical Ltd.
Enrollment
190 participants
Start Date
Mar 11, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 22 Years
Inclusion Criteria5
- 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 Criteria7
- 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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Interventions
DIAGNOSTIC_TESTxBar 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.
Locations(13)
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NCT06168669
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