NCT06039085

Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Ryan J. Halter · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	custom device to demonstrate a significant difference in electrical impedance signatures	Custom device will be used to measure electrical impedance signatures.

Timeline

• Start date: 2023-11-03
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-09-15
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States