Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar (NCT07337590) | Clinical Trial Compass
RecruitingNot Applicable
Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
United States80 participantsStarted 2026-03-10
Plain-language summary
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Who can participate
Age range
21 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
. Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
. Expected anastomosis within 10 cm from the anal verge
. Usage of drain during the surgery (to be confirmed during the surgery)
. Willing and able to comply with the study follow up and able and agree to provide informed consent.
. Adults aged ≥21 years at the time of surgery.
. Underwent a low anterior resection (LAR) for malignant colorectal disease.
. Documented colorectal anastomosis located \<10cm from the anal verge, or documented tumor \<10cm from the anal verge. Complete documentation for the index hospitalization and for the required 12-month follow-up period, or up to stoma take down procedure whichever came first.
Exclusion criteria
. Subjects with benign disease
. Contraindication for surgery and/or general anesthesia.
. Known 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
Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohorts
Timeframe: At the time points of 30 and 90 days following index surgery
2
Primary Safety Endpoint - No Unexpected Serious Adverse Device Events within the Intent to Treat population during the study period ( up to 365 days following index surgery)
Timeframe: from the date of index surgery up to 365 days following the index surgery