Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: custom device to demonstrate a significant difference in electrical impedance signatures.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment
Overview
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).
Interventions
- Device custom device to demonstrate a significant difference in electrical impedance signatures
Custom device will be used to measure electrical impedance signatures.
Primary outcome measures
- Electrical impedance difference between positive and negative surgical margins [Time frame: 2023-2025]
Secondary outcome measures (2)
- Safety of EI sensing in vivo electrical sensing [Time frame: 2023-2025]
- Efficacy of EI sensing in vivo electrical sensing [Time frame: 2023-2025]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Dartmouth-Hitchcock Medical Center — Lebanon
Identifiers
NCT: NCT06039085 · STUDY02001660