Collection of Electrophysiological Data During Colon Resection

Study Overview
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Brief Summary
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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.

Official Title
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Data Collection Study - Recording Electro-physiological Signals From Intact (to be Resected, Pathological) and Ischemic Bowel Tissue During Open Colonic Surgery.

Conditions
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Open/ Laparoscopic/ Robotic Resection of the Colon

Intervention / Treatment
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* Device: Exero Medical Leak Detection System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Patient is scheduled for open colonic resection, (right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection or subtotal colectomy) surgery. Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out. Exclusion Criteria: Subject has gastroparesis. Subject has significant multisystem (autonomic) diseases. Subject has a body mass Index greater than 35 kg/m2 Subject has an autoimmune disorder requiring therapy in the preceding 2 years. Subject has significant cardiac arrhythmia or ectopy. Obstructing lesion and pre obstruction bowel dilatation Subject has an existing implanted electrical stimulator (e.g., pacemaker. Subject requires chronic anticoagulant therapy Subject is currently enrolled in other potentially confounding research. Pregnancy Current alcohol abuse Subject poses a significant general anesthesia risk Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.

Ages Eligible for Study
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Minimum Age: 18 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impedance measurement<br>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. | Device: Exero Medical Leak Detection System<br>* the Exero Leak Detection System components used in this study are: Smart drain - a surgical drain with added sensing electrodes Transceiver /Recording Unit (TRU) - a wearable placed outside the body on intact skin and is connected to the implanted electrodes. The unit also acts as a wireless connection to the Monitoring Subsystem. Monitoring Subsystem - a tablet or a computer connected wirelessly to the transceiver providing logging, applying analysis algorithms on the logged signals and providing indication/alerts to the medical staff derived from the signals recorded by the electrodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemia, Exero, anastomotic leak, impedance, colon, bowel