Trials / Completed
CompletedNCT04574401
A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
A Phase 1 Safety and Efficacy Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Intuitive Surgical · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IS-002 | Intravenous injection of IS-002 Investigational Drug |
Timeline
- Start date
- 2020-10-10
- Primary completion
- 2021-09-20
- Completion
- 2021-09-20
- First posted
- 2020-10-05
- Last updated
- 2021-10-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04574401. Inclusion in this directory is not an endorsement.