IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery

Intuitive Surgical189 enrolled

Overview

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.

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 efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

189

Conditions

Ureter Injury

Interventions

IS-001DRUG

IV injection of IS-001 drug substance with near infrared (NIR) imaging

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female subject is between the ages of 16 and 75, inclusive at time of consent. 2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging. 3. Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable. Exclusion Criteria: 1. Subject is pregnant or nursing. 2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 3. Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months 4. 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 5. Subject has a known or suspected hypersensitivity to indocyanine green (ICG) 6. Subject has any of the following screening laboratory values: 1. eGFR \< 60 mL/min/1.73 m\^2 2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN 3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN. 7. Planned use of CYTALUX™ (pafolacianine) for surgery

Locations (8)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

HCA Mercy Hospital

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

E.W. Sparrow Hospital

Lansing, Michigan, United States

Outcomes

Primary Outcomes

Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.

Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection

Time frame: 10 minutes

Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible

Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after IS-001 injection

Time frame: 30 minutes

Secondary Outcomes

Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length

Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after injection

Time frame: 10

Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length

Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 30 minutes after injection

Time frame: 30

Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible

Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 10 minutes after IS-001 injection

Data from ClinicalTrials.gov

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MountainView Hospital

Las Vegas, Nevada, United States

The Ohio State Unversity

Columbus, Ohio, United States

OhioHealth

Columbus, Ohio, United States

St. David's Surgical Hospital

Austin, Texas, United States

Time frame: 10 minutes

Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible

Time frame: 30 minutes

Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible

Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection

Time frame: 45 minutes

Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length

Evaluate ureter length delineation by independent reader at (a) the pelvic brim and (b) uterine arteries location in Firefly® mode compared to white light mode at 45 minutes after IS-001 injection

Time frame: 45 minutes

Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible

Time frame: 45 minutes

Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode

Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.

Time frame: 10 minutes

Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode

Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.

Time frame: 30 minutes

Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode

Evaluate ureter signal-to-background ratio in Firefly imaging across time points at (a) the pelvic brim location and (b) the uterine arteries location after IS-001 injection.

Time frame: 45 minutes

concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Determine degree of concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment at (a) the pelvic brim location and (b) the uterine arteries location

Time frame: 10 minutes

concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Time frame: 30 minutes

concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment

Time frame: 45 minutes

Determine degree of concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location

Time frame: 10 minutes

Determine degree of concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location

Time frame: 30 minutes

Determine degree of concordance of ureter visualization between independent readers

Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location

Time frame: 45 minutes

degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location

Time frame: 10 minutes

degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location

Time frame: 30 minutes

degree of concordance of ureter visualization within independent readers

Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location

Time frame: 45 minutes