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.
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: 1. In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected 2. Resected ex vivo prostate following extraction from the abdomen (in the OR) 3. 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).
Study Type
OBSERVATIONAL
Enrollment
200
Custom device will be used to measure electrical impedance signatures.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
RECRUITINGElectrical 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.
Time frame: 2023-2025
Safety of EI sensing in vivo electrical sensing
Secondary outcome measures will include number of study-related adverse events documented.
Time frame: 2023-2025
Efficacy of EI sensing in vivo electrical sensing
Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment
Time frame: 2023-2025
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