Phase
Condition
N/ATreatment
IS-001
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Inclusion Criteria
Female subject is between the ages of 18 and 75, inclusive.
Subject is scheduled to undergo robotic-assisted gynecological procedure using a daVinci® surgical system with Firefly® fluorescent imaging.
Subject is willing and able to provide informed consent.
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:
Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × upper limit normal (ULN)
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × upper limit normal (ULN).
Study Design
Study Description
Connect with a study center
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United StatesActive - Recruiting
HCA Mercy Hospital
Miami, Florida 33133
United StatesActive - Recruiting
Orlando Health
Orlando, Florida 32806
United StatesActive - Recruiting
E.W. Sparrow Hospital
Lansing, Michigan 48912
United StatesSite Not Available
MountainView Hospital
Las Vegas, Nevada 89128
United StatesActive - Recruiting
OhioHealth
Columbus, Ohio 43214
United StatesActive - Recruiting
The Ohio State Unversity
Columbus, Ohio 43210
United StatesActive - Recruiting
St. David's Surgical Hospital
Austin, Texas 78681
United StatesActive - Recruiting
The Hospital of Providence Transmountain Campus
El Paso, Texas 79911
United StatesSite Not Available
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