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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xBar results, and the system.

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

Conditions
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Colorectal Surgery, Anastomotic Leak

Intervention / Treatment
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* Diagnostic Test: xBar system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 22 years Indication for sigmoid or rectal resection surgery. Usage of drain during the surgery (to be confirmed during the surgery) Willing and able to comply with the study follow up. Able and agree to provide an informed consent. Exclusion Criteria: Contraindication for surgery and/or general anesthesia. Pregnancy or lactation. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery) Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator). Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel. Participation in another interventional study during the xBar system usage.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All eligible subjects will be assigned with the investigational device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Singel arm<br>All patients will be treated with the investigational device. | Diagnostic Test: xBar system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Lack of unanticipated serious adverse events related to the xBar system or xBar procedure during the study period. | through study completion, an average of 1 year | 
| Safety - Severe leak rate - comparable to SOC. | Statistical evaluation of prevalence of anastomotic leaks in the study group compared to the prevalence present in the literature. | through study completion, an average of 1 year | 
| Performance - successful xBar placement. | The device is working properly and records data in 90% of the cases or more. | through study completion, an average of 1 year | 
| Performance - Sensitivity and Specificity of severe leak detection | Sensitivity and Specificity are non-inferior compared to Standard of care at POD 3 | through study completion, an average of 1 year |