IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
Recruiting
Phase 3
Interventional Study
Ureter Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 146 (estimated)
- Sponsor
- Intuitive Surgical · Industry
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About This Trial
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male and female participants between the ages of 16 and 75, inclusive
2. Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging Exclusion Criteria
1\. Participant is pregnant or nursing 2. Particip…
Contacts