IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
- Conditions
- Ureter Injury
- Interventions
- Drug: IS-001
- Registration Number
- NCT05954767
- Lead Sponsor
- Intuitive Surgical
- Brief Summary
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
- Detailed 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 efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 237
Inclusion Criteria
- Female subject is between the ages of 18 and 75, inclusive.
- Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® surgical system with Firefly® fluorescent imaging.
- Subject is willing and able to provide informed consent.
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Subject is pregnant or nursing.
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Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
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Subject is already enrolled in another investigational drug or device study receiving therapeutic agents within the past 6 months
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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.
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Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
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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 Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Efficacy IS-001 Single intravenous injection of IS-001 and ureter visualization and delineation will be compared in white light standard of care and near-infrared (NIR) imaging mode.
- Primary Outcome Measures
Name Time Method 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 30 minutes 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
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. 10 minutes 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
- Secondary Outcome Measures
Name Time Method degree of concordance of ureter visualization within independent readers 45 minutes Determine degree of concordance of ureter visualization within independent readers at (a) the pelvic brim location and (b) the uterine arteries location
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 45 minutes 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
Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode 45 minutes 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.
concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment 45 minutes 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
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length 45 minutes 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
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 45 minutes 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 45 minutes after IS-001 injection
Determine degree of concordance of ureter visualization between independent readers 45 minutes Determine degree of concordance of ureter visualization between independent readers at (a) the pelvic brim location and (b) the uterine arteries location
Trial Locations
- Locations (9)
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
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
The Hospital of Providence Transmountain Campus
🇺🇸El Paso, Texas, United States