drugset / Trial / NCT04574401

A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy

NCT04574401 ↗

Phase 1 Completed 24 enrolled Intuitive Surgical
NaSequentialOpen-labelOther

Summary

This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.

Timeline

Start
2020-10-10
Primary completion
2021-09-20
Completion
2021-09-20

Drugs

EvaluationDrugModalityDoseRoute
Subject IS-002 Diagnostic / imaging agent — Intravenous

Indications