xBar System for Colorectal Cancer
(ASSURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.
Are You a Good Fit for This Trial?
This trial is for adults over 21 who are scheduled for elective low anterior resection due to colorectal cancer. Participants must have an expected anastomosis within 10 cm from the anal verge and agree to use a drain during surgery. They should be willing to follow study procedures and provide informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Placement of the xBar system during elective low anterior resection surgery and continuous monitoring until drain removal
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of xBar's performance and stoma-free status
Long-term follow-up
Monitoring for any unexpected serious adverse device events and health resource utilization
What Are the Treatments Tested in This Trial?
Interventions
- xBar™ System
Trial Overview
The xBar™ System is being tested in this trial, which aims to see if it improves clinical outcomes after colorectal surgery. The study will compare results from patients using the system with historical data of those who did not.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The xBar drain will be placed during the elective low anterior resection, which will be performed according to each medical center's standard surgical procedures. Following placement, the xBar system will continuously collect measurements until drain removal.
A de-identified historical cohort consisting of a matched population that underwent surgical procedures during 2023. Historical data will include subject demographics, initial diagnosis, index surgery details, tumor location, comorbidities, length of stay (LOS), and readmission rates following the index colorectal surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exero Medical Ltd.
Lead Sponsor
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