A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitori… (NCT06168669) | Clinical Trial Compass
CompletedNot Applicable
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
United States, Israel222 participantsStarted 2023-03-11
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety
Timeframe: through study completion, an average of 1 year
2
Safety - Severe leak rate - comparable to SOC.
Timeframe: through study completion, an average of 1 year
3
Performance - successful xBar placement.
Timeframe: through study completion, an average of 1 year
4
Performance - Sensitivity and Specificity of severe leak detection
Timeframe: through study completion, an average of 1 year