NCT07516808

PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing radical prostatectomy in participants with prostate cancer.

Detailed description

This prospective, single-arm feasibility study is to evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing robot-assisted laparoscopic radical prostatectomy (RP) in participants with prostate cancer. A nonlinear microscope is a rapid imaging technology that can quickly image the surface of the prostate after it has been removed from the body to see if there is any cancer left behind. The U.S. Food and Drug Administration (FDA) has not approved the NLM device for use in assessing radical prostatectomy surgical specimens but has been approved for other uses. The research study procedures include screening for eligibility and standard of care radical prostatectomy surgery. It is expected about 20 people will participate in this research study. The National Institutes of Health is supporting this research study by providing study funds. The Masssachusetts Institute of Technology (MIT) is supporting this research by providing the nonlinear microscope.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Nonlinear Microscope (NLM)	The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins.

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-08-28
• Completion: 2027-08-28
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study