Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen

Not Applicable

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT07141121
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

This study investigates a new, faster way to find cancer cells on the surface of the prostate during radical prostatectomy surgery. A recently FDA-approved device, called the Histolog Scanner, gives high-resolution imaging of the surface of fresh tissue using ultra-fast confocal microscopy, which allows physicians to make surgical decisions quickly.

Detailed Description

The goal of this time saving feasibility study is to gain early insights into whether Histolog Scanner can maintain the integrity and safety of NeuroSafe margin assessment while alleviating the heavy time burden of NeuroSafe in the US setting before starting a larger clinical trial. This way, patients can be offered optimal nerve sparing without adding to the administrative burden and cost associated with NeuroSafe. What is new about the study is that the researchers intend to do a cost and time economics analysis using United States market prices that will inform discussions in the future about the utility of this device in the United States.

Study Timeline

• Study Start: 2025-05-13
• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-26
• Last Update Posted: 2025-08-26
• Primary Completion: 2026-05-13
• Study Completion: 2026-05-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes	Immediately after procedure	Defined as a positive difference of time taken using NeuroSafe technique vs time taken by Histolog scanner in margin assessment.

Secondary Outcome Measures

Name	Time	Method
Agreement Between Histolog and Final Histopathology Assessment	Immediately after procedure	The Kappa statistic (Cohen's Kappa) will be used to assess agreement between Histolog and final histopathology assessment. 95% CI will be calculated using the Wilson's method without continuity correction.
System Usability Scale (SUS)	"Baseline" or "Day 1" and through study completion, an average of 1 year	System Usability Scale (SUS) ranges between 8-40. Each question asks about ease of use of the Histolog Scanner, and the operator answers each of the 8 questions on a scale of 1 (strongly disagree) to 5 (strongly agree). Any SUS score greater than or equal to 32 will be interpreted as high usability.; Operator will be asked to complete after the completion of every 10 procedures and again after the final procedure.
Pathologist Usability Scale (PUS) score	"Baseline" or "Day 1" and through study completion, an average of 1 year	Pathologist Usability Scale (PUS) ranges between 6-30. Each question asks about the ease of use of the Histolog Scanner, and the pathologist answers each of the 6 questions on a scale of 1 (strongly disagree) to 5 (strongly agree). Any PUS score greater than or equal to 25 will be interpreted as high pathologist usability.; Pathologist will be asked to complete after the completion of every 10 procedures and again after the final procedure.
Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology	Immediately after procedure	Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States