A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Exero Medical Ltd.
Summary
Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system.
Description
Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion. xBar is an investigational device intended for post-op monitoring of patients undergoing GI surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications. Study description: The study is inten…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Diagnostic TestxBar system
xBar system is surgical drain with embedded sensors. Collected data will be evaluated for an ability to identify anastomotic leaks. The xBar system does not have therapeutic indication.
Locations (13)
- AdventHealth OrlandoOrlando, Florida
- AdventHealth TampaTampa, Florida
- University of LouisvilleLouisville, Kentucky
- Henry Ford HealthDetroit, Michigan
- Bryan Medical CenterLincoln, Nebraska
- Weill Cornell MC, NYNew York, New York