Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06039085
• Lead Sponsor: Ryan J. Halter

Brief 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).

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Start: 2023-11-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electrical impedance difference between positive and negative surgical margins	2023-2025	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States