Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
200Conditions
Prostate CancerSummary
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).
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Lawrence M Dagrosa, MD
- 603-650-8123
- [email protected]
Principal Investigator
- Ryan J Halter, PhD
Eligibility Criteria
Inclusion Criteria:
1. Clinical diagnosis of prostate cancer requiring RARP.
2. Ability to understand and the willingness to sign a written informed consent document.
3. Age ≥ 18 years old
Exclusion Criteria:
1. Adults with implanted electrical devices such as pacemakers
2. Prisoners
3. Adults with impaired decision-making capacity
4. Any condition for which, in the opinion of the investigator, contraindicates study participation.
Outcome Measures
Primary Outcome Measures
Electrical impedance difference between positive and negative surgical margins
Secondary Outcome Measures
Safety of EI sensing in vivo electrical sensing
Efficacy of EI sensing in vivo electrical sensing
Timeline
Last Updated
January 24, 2024Start Date
September 15, 2023Today
February 5, 2025Completion Date ( Estimated )
December 31, 2026
Sponsors of this trial
Lead Sponsor
Ryan J. HalterCollaborating Sponsors
Dartmouth College
RECRUITING 
21 - 64 Years