Anastomotic Leak, Colorectal Surgery
Conditions
Brief 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.
Detailed 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 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.
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.
Sponsors
Exero Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Investigators, clinical teams and subjects will be blinded to the outcomes provided by xBar system. Post operative monitoring will be as per SOC.
Intervention model description
All eligible subjects will be assigned with the investigational device.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | through study completion, an average of 1 year | Incidence of Unanticipated Serious Adverse Events Related to the xBar System or xBar Procedure |
| Safety - Severe leak rate - comparable to SOC. | through study completion, an average of 1 year | Incidence of Severe Anastomotic Leak. Statistical evaluation of prevalence of anastomotic leaks in the study group compared to the prevalence present in the literature. |
| Performance - xBar Technical Success Rate | through study completion, an average of 1 year | xBar Technical Success Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | From the xBar placement up to POD3 | Sensitivity of xBar for Detection of Severe Anastomotic Leak assuming is non-inferior compared to Standard of care at POD 3 |
| Specificity | from the xBar placement up to post operative day 3 | Specificity of xBar for Detection of Severe Anastomotic Leak assuming is non -inferior to standard of care detection |
Countries
Israel, United States
Outcome results
None listed