Validation of xBar System for Detecting Post-Operative Leaks

A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

This study is testing a new monitoring tool called xBar to see if it can help doctors quickly find leaks after colorectal surgery in patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Exero Medical Ltd. (Industry-sponsored)
• Locations: 13 sites (Orlando, Florida and 12 other locations)
• Trial ID: NCT06168669 on ClinicalTrials.gov

What this trial studies

This study aims to validate the safety and effectiveness of the xBar monitoring tool for detecting anastomotic leaks in patients undergoing colorectal surgery. Approximately 190 subjects will be enrolled, and the xBar device will be placed during surgery to monitor for complications over a period of at least three days. The clinical team will be blinded to the device's results, allowing for an unbiased comparison of the xBar's performance against the clinical team's diagnosis. The goal is to enhance early detection of post-operative complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older who are scheduled for sigmoid or rectal resection surgery with planned drain usage.

Not a fit: Patients with contraindications for surgery, those who are pregnant or lactating, or individuals with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection of anastomotic leaks, potentially reducing complications and enhancing patient outcomes.

How similar studies have performed: While the xBar system is an investigational device, similar monitoring approaches have shown promise in enhancing post-operative care, though this specific application is novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 22 years
2. Indication for sigmoid or rectal resection surgery.
3. Usage of drain during the surgery (to be confirmed during the surgery)
4. Willing and able to comply with the study follow up.
5. Able and agree to provide an informed consent.

Exclusion Criteria:

1. Contraindication for surgery and/or general anesthesia.
2. Pregnancy or lactation.
3. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
4. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
5. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
6. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
7. Participation in another interventional study during the xBar system usage.

Where this trial is running

Orlando, Florida and 12 other locations

• AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
• AdventHealth Tampa — Tampa, Florida, United States (Recruiting)
• University of Louisville — Louisville, Kentucky, United States (Recruiting)
• Henry Ford Health — Detroit, Michigan, United States (Not_yet_recruiting)
• Bryan Medical Center — Lincoln, Nebraska, United States (Recruiting)
• Weill Cornell MC, NY — New York, New York, United States (Recruiting)
• Mount Sinai Health System — New York, New York, United States (Recruiting)
• Northwell Health, NY — New York, New York, United States (Recruiting)
• Stony Brook University Hospital and Cancer Center — New York, New York, United States (Recruiting)
• Hca — Houston, Texas, United States (Recruiting)
• Soroka MC — Beersheba, Israel (Recruiting)
• Rabin MC — Petah Tikva, Israel (Recruiting)
• Kaplan MC — Rehovot, Israel (Recruiting)

Study contacts

• Study coordinator: Ilana Fishman

Conditions Colorectal Surgery; Anastomotic Leak