xBar System for Colorectal Cancer
(ASSURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the xBar System to evaluate its effectiveness in aiding recovery after colorectal surgery. The xBar System, a special drain used during surgery, collects important recovery data. The trial compares new patients using the xBar System with past patients who underwent similar surgeries. It suits adults scheduled for elective surgery to remove colorectal cancer and who require a drain during their procedure. Participants must agree to follow up after surgery and provide informed consent. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery outcomes for future patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the xBar System is safe for use in colorectal surgery recovery?
Research is investigating whether the xBar™ System can improve recovery after colorectal surgery. Studies have found that most patients tolerate it well. One study assessed its safety and effectiveness in spotting leaks post-surgery. Another study demonstrated its ability to detect changes in the body's signals, aiding in tracking recovery.
Clear evidence of serious side effects with the xBar System has not emerged. However, as testing continues, researchers closely monitor any potential issues. Prospective trial participants should discuss any concerns or questions with their doctor.12345Why are researchers excited about this trial?
The xBar™ System is unique because it offers a continuous measurement approach during colorectal cancer surgeries, which isn't a feature of current treatments. Standard treatments typically involve post-operative monitoring without real-time data collection. The xBar system is integrated into the surgical process, allowing for ongoing data collection until the drain is removed. This could lead to a deeper understanding of patient recovery and potentially reduce complications by providing immediate insights into surgical outcomes. Researchers are excited because this system could redefine post-surgery monitoring, offering a more precise and proactive way to manage patient care.
What evidence suggests that the xBar system is effective for recovery following colorectal surgery?
Research shows that the xBar™ System is being tested in this trial to enhance recovery after colorectal surgery. Participants in the interventional cohort will have the xBar drain placed during their elective low anterior resection, allowing for continuous monitoring until drain removal. This system aims to closely monitor patients and potentially improve their recovery. While specific data on its effectiveness is still being collected, the goal is to enhance recovery by tracking important health signs during healing. Early results from similar systems suggest that this type of monitoring can lead to better recovery experiences and outcomes for patients. The xBar System aims to offer these benefits to those undergoing colorectal surgery.14678
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
Citations
Anastomotic Safety and Surveillance Using Real-time ...
The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery.
xBar System for Colorectal Cancer (ASSURE Trial)
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 ...
Effects of low anterior resection syndrome after colorectal ...
The study findings suggest that patients with major LARS experience worse HRQOL compared to those with minor/no LARS.
Strategic efforts for optimal outcomes in patients with low ...
Strategic efforts for optimal outcomes in patients with low anterior resection syndrome (LARS) at the Vanderbilt-Ingram Cancer Center (VICC).
Studies in Patients With Low Anterior Resection Syndrome ...
With recent development in oncological and surgical treatments for rectal cancer, many patients are receiving sphincter-preserving surgery with low colorectal ...
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ctv.veeva.com
ctv.veeva.com/study/anastomotic-safety-and-surveillance-using-real-time-enhanced-sensing-using-xbarAnastomotic Safety and Surveillance Using Real-time Enhanced ...
The study is intended to evaluate the effect of xBar utilization on clinical outcomes during recovery from colorectal surgery. During the study, patients in ...
A Safety and Effectiveness Prospective Blinded Clinical ...
Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects ...
Post-operative monitoring of intestinal motility, ischemia ...
This study demonstrates clinical feasibility of the xBar system. Local electrophysiological parameters are highly sensitive to the physiological ...
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