Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment

Study Overview
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Brief Summary
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This research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. This device is called an Electrical Impedance Imaging (EII) probe.

Detailed Description
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Two hundred men will be recruited to participate in this trial. Consent will be obtained from all participating men prior to surgery. The trial will consist of recording EII data from: In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected Resected ex vivo prostate following extraction from the abdomen (in the OR) Resected ex vivo prostate when transferred to Pathology, post-RARP The study team will also track post-surgical complications due to the study's technology (e.g., infection) and additional time required to deploy the study technology used to assess feasibility of clinical integration of the EII device. Post-RARP pathological assessment of margin tissues will be used to train and evaluate the study's classification schemes for identifying Positive Surgical Margin (PSMs).

Official Title
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Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: custom device to demonstrate a significant difference in electrical impedance signatures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of prostate cancer requiring RARP. Ability to understand and the willingness to sign a written informed consent document. Age ≥ 18 years old Exclusion Criteria: Adults with implanted electrical devices such as pacemakers Prisoners Adults with impaired decision-making capacity Any condition for which, in the opinion of the investigator, contraindicates study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: custom device to demonstrate a significant difference in electrical impedance signatures|Custom device will be used to measure electrical impedance signatures.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical impedance difference between positive and negative surgical margins | Outcome measures will include how significantly different electrical impedance signatures are between impedance recordings of positive and negative surgical margins as acquired during prostate surgery. | 2023-2025 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of EI sensing in vivo electrical sensing | Secondary outcome measures will include number of study-related adverse events documented. | 2023-2025 | 
| Efficacy of EI sensing in vivo electrical sensing | Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment | 2023-2025 |