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The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impedance measurement | Experimental | Subjects with Exero's Smart Drain Device Attached This arm contains subjects which will have Exero's leak detection Device used: Exero Smart Drain is placed on their large bowel during colonic resection surgery (either open, laparoscopic or robotic). The study aims to demonstrate that the parameters measured by the device in in-vivo, non-disrupted tissue are different than parameters measured in ischemic tissue. Once this data is collected a detection algorithm can be trained. This procedure will add no more than 20 minutes to the existing procedure that is performed per hospital standard overall and will enable collection of control vs. ischemia induced clinical data, essential to developing the detection algorithms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exero Medical Leak Detection System | Device | the Exero Leak Detection System components used in this study are:
|
| Measure | Description | Time Frame |
|---|---|---|
| Functionality of signal measurement | Baseline data collected from the intended bowel segment to be resected, prior to tissue manipulation, is compared to the data recorded after the ischemia induced by the resection procedure. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | Adverse events both expected and unexpected, related or unrelated to study device or procedure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nir Wasserberg, MD | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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