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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Singel arm | Other | All patients will be treated with the investigational device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xBar system | Diagnostic Test | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Orlando | Orlando | Florida | 328803 | United States | ||
| AdventHealth Tampa |
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All eligible subjects will be assigned with the investigational device.
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Investigators, clinical teams and subjects will be blinded to the outcomes provided by xBar system. Post operative monitoring will be as per SOC.
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| Tampa |
| Florida |
| 33613 |
| United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| Bryan Medical Center | Lincoln | Nebraska | 68506 | United States |
| Weill Cornell MC, NY | New York | New York | 10021 | United States |
| Mount Sinai Health System | New York | New York | 10029 | United States |
| Northwell Health, NY | New York | New York | 10075 | United States |
| Stony Brook University Hospital and Cancer Center | New York | New York | 11794-8191 | United States |
| HCA | Houston | Texas | 77030 | United States |
| Soroka MC | Beersheba | Israel |
| Rabin MC | Petah Tikva | Israel |
| Kaplan MC | Rehovot | Israel |
| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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