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This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Full description
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and feasibility of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.
Enrollment
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Inclusion criteria
Exclusion criteria
Subject is pregnant or nursing
Subject has known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Subject has any of the following screening laboratory values:
Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
Subjects with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used.
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Central trial contact
Karen Hwang
Data sourced from clinicaltrials.gov
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