Phase
Condition
N/ATreatment
IS-001
Clinical Study ID
Ages 16-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female subject is between the ages of 16 and 75, inclusive at time of consent.
Subject is scheduled to undergo robotic-assisted gynecological procedure using a daVinci® Surgical System with Firefly® Fluorescence Imaging.
Subject and/or subject's parent/guardian is willing and able to provide informedconsent and/or assent as applicable.
Exclusion
Exclusion Criteria:
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 drug or device studyreceiving therapeutic agents within the past 6 months
Subject has any other condition or personal circumstance that, in the judgment ofthe Investigator, might interfere with the collection of complete quality data orrepresents an unacceptable safety profile
Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
Subject has any of the following screening laboratory values:
eGFR < 60 mL/min/1.73 m^2
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.
Planned use of CYTALUX™ (pafolacianine) for surgery
Study Design
Study Description
Connect with a study center
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United StatesSite Not Available
Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
HCA Mercy Hospital
Miami, Florida 33133
United StatesSite Not Available
Orlando Health
Orlando, Florida 32806
United StatesSite Not Available
HCA Mercy Hospital
Miami 4164138, Florida 4155751 33133
United StatesSite Not Available
Orlando Health
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
E.W. Sparrow Hospital
Lansing, Michigan 48912
United StatesSite Not Available
E.W. Sparrow Hospital
Lansing 4998830, Michigan 5001836 48912
United StatesSite Not Available
MountainView Hospital
Las Vegas, Nevada 89128
United StatesSite Not Available
MountainView Hospital
Las Vegas 5506956, Nevada 5509151 89128
United StatesSite Not Available
OhioHealth
Columbus, Ohio 43214
United StatesSite Not Available
The Ohio State Unversity
Columbus, Ohio 43210
United StatesActive - Recruiting
OhioHealth
Columbus 4509177, Ohio 5165418 43214
United StatesSite Not Available
The Ohio State Unversity
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
St. David's Surgical Hospital
Austin, Texas 78681
United StatesSite Not Available
The Hospital of Providence Transmountain Campus
El Paso, Texas 79911
United StatesSite Not Available
St. David's Surgical Hospital
Austin 4671654, Texas 4736286 78681
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.