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.
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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

Clinical Project Manager

4085232100

info.is-001@intusurg.com

CONTACT