Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment

Prostate Cancer Clinical Trial

— RARP EI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039085
• Other study ID #: STUDY02001660
• Status: Recruiting
• Start date: November 3, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Ryan J Halter, PhD
• Phone: (603) 646-0773
• Email: Ryan.J.Halter[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• custom device to demonstrate a significant difference in electrical impedance signatures
Custom device will be used to measure electrical impedance signatures.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Ryan J. Halter	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical 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.	2023-2025
Secondary	Safety of EI sensing in vivo electrical sensing	Secondary outcome measures will include number of study-related adverse events documented.	2023-2025
Secondary	Efficacy of EI sensing in vivo electrical sensing	Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment	2023-2025