Finished
A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
NCT03937505 · Intuitive Surgical · Updated 5 Aug 2021
- What is being tested
- IS-001; No treatment
- For
- Ureter Injury
- Kind of study
- Tests a treatment or device on volunteers. Phase 2.
- Who can join
- Ages 18 years to 75 years. About 94 people. The full rules are on the registry page.
- Where
- United States (3 sites)
- When
- Starts or started 28 May 2019, ends 22 July 2021. Registered 3 May 2019.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- George Washington University HospitalWashington D.C., District of Columbia, United States
- St.David's Medical CenterAustin, Texas, United States
- Las Palmas Medical CenterEl Paso, Texas, United States