A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
Completed · Phase 2
Conditions studied: Ureter Injury
In brief
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.
Key facts
- Study ID
- NCT03937505
- Run by
- Intuitive Surgical
- People needed
- 94
- Starts
- 2019-05-28
- Expected to finish
- 2021-07-22
- Last updated by the study team
- 2021-08-05
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female subject is between the ages of 18 and 75, inclusive
- Subject is scheduled to undergo robotic gynecological surgery using a da Vinci® surgical system with Firefly® fluorescent imaging
- Subject is willing and able to provide informed consent
- Subject is considered capable of complying with study procedures
You may not qualify if…
- Subject is pregnant or nursing
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Subject is already enrolled in another investigational study 5. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
Where it is running
- George Washington University Hospital — Washington D.C., District of Columbia, United States
- St.David's Medical Center — Austin, Texas, United States
- Las Palmas Medical Center — El Paso, Texas, United States
Full record on ClinicalTrials.gov
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