A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy

Summary

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.

Timeline

Start

2019-05-28

Primary completion

2021-07-08

Completion

2021-07-22

Drugs

Indications