xBar System for Colorectal Cancer Surgery Recovery
This study is looking at how well the xBar™ System helps people recover after surgery for colorectal cancer. The xBar™ System is a device that fits into a standard surgical drain to continuously monitor your recovery after surgery. Researchers want to see if using the xBar™ System leads to better outcomes compared to past patients who didn't use it. They will compare things like overall health, hospital visits, and whether a temporary ostomy (stoma) is needed. You might be able to join if you are at least 21 years old, having surgery for colorectal cancer, and a drain is used during your surgery. The study aims to show that the xBar™ System is at least as good as standard care and does not cause unexpected serious problems. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 80 participants. It compares patients using the xBar™ System to a group of past patients who had similar surgery.
- What's involved
- If you are in the intervention group, the xBar™ device will be placed during your surgery. You will need to comply with study follow-up appointments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 365 days after your surgery. Effectiveness will be checked at 30 and 90 days after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
At a glance
Conditions
Where it's being run
6 sites across 5 statesWho to contact
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What this trial measures
- Primary Effectiveness Endpoint-Demonstrate non-inferiority between the study interventional and historical cohortsAt the time points of 30 and 90 days following index surgery
Non-inferiority of the mean Modified Comprehensive Complication Index (MCCI) of the modified intent-to-treat (mITT) population at 30 days following the index surgery, compared with the MCCI of the matched historical cohort.
- 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)from the date of index surgery up to 365 days following the index surgery
Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period ( up to 365 days from the index surgery)