drugset / Trial / NCT05946603

IS-002 Phase 2 Prostate Cancer Study

NCT05946603 ↗

Phase 2 Completed 59 enrolled Intuitive Surgical
RandomizedParallel-groupOpen-labelOther

Summary

Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgical System with Firefly® Fluorescence Imaging.

Timeline

Start
2023-06-16
Primary completion
2024-05-21
Completion
2025-05-23

Drugs

EvaluationDrugModalityDoseRoute
Subject IS-002 Diagnostic / imaging agent — Intravenous

Indications