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

Launched by EXERO MEDICAL LTD. · Dec 12, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a tool called the xBar system, which is designed to help detect leaks that can occur after certain colorectal surgeries, specifically those involving the rectum or sigmoid colon. An anastomotic leak is a complication where the connection made during the surgery doesn't heal properly, which can lead to serious health issues. In this study, the clinical team will not know whether the xBar system indicates a leak or not, ensuring an unbiased evaluation of its effectiveness and safety.

To participate in this trial, individuals must be at least 22 years old and scheduled for sigmoid or rectal surgery that will involve the use of a drain. Participants should be able to follow up after their surgery and will need to agree to provide informed consent. However, not everyone will qualify; for instance, those who are pregnant, have certain medical conditions, or have specific implanted devices will be excluded. If eligible, participants can expect close monitoring after their surgery to see if the xBar system successfully detects any leaks, helping to improve future patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 22 years
• • 2. Indication for sigmoid or rectal resection surgery.
• • 3. Usage of drain during the surgery (to be confirmed during the surgery)
• • 4. Willing and able to comply with the study follow up.
• • 5. Able and agree to provide an informed consent.
• Exclusion Criteria:
• • 1. Contraindication for surgery and/or general anesthesia.
• • 2. Pregnancy or lactation.
• • 3. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
• • 4. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
• • 5. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
• • 6. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
• • 7. Participation in another interventional study during the xBar system usage.