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| Name | Class |
|---|---|
| SamanTree Medical SA | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing robotic-assisted radical prostatectomy | Experimental | Patients undergo standard of care (SOC) robotic-assisted radical prostatectomy. The patients' removed prostates are then evaluated with the Histolog Scanner. Patients also undergo SOC blood sample collection, rectal examination, MRI, and micro ultrasound imaging, as well as have their medical records reviewed throughout the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Histolog Scan | Device | Upon prostate removal, the prostate is taken to the Histolog scanner, dipped in proprietary fluorescent dye, rinsed with saline, and then scanned on five different sides. This involves simply placing the prostate on the surface of the scanner and acquiring images on each side, giving a high-resolution (cellular level) microscopic imaging of the prostate's surfaces. Once images are collected, the prostate is returned to the pathology lab to undergo the NeuroSafe procedure, which is standard of care (SOC). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes | Defined as a positive difference of time taken using NeuroSafe technique vs time taken by Histolog scanner in margin assessment. | Immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between Histolog and Final Histopathology Assessment | 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. | Immediately after procedure |
| System Usability Scale (SUS) |
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Inclusion criteria:
Exclusion criteria:
This study is looking at post-surgical specimens for patients with prostate cancer, so the researchers are only looking at a male population.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monali Fatterpekar, PhD | Contact | (347) 675-8024 | +1 | monali.fatterpekar@mountsinai.org |
| Henry W. Jodka, BA | Contact | 203-939-5115 | +1 | henry.jodka@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Ashutosh K. Tewari, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Specify Other Time FrameTBD
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (to be determined).
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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. |
| "Baseline" or "Day 1" and through study completion, an average of 1 year |
| Pathologist Usability Scale (PUS) score | 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. | "Baseline" or "Day 1" and through study completion, an average of 1 year |
| Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology | Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology | Immediately after procedure |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |