Ureter Injury Clinical Trial
Official title:
A Phase 3 Multi-Center Efficacy Study of IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
Status | Recruiting |
Enrollment | 237 |
Est. completion date | July 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: Inclusion Criteria 1. Female subject is between the ages of 18 and 75, inclusive. 2. Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® surgical system with Firefly® fluorescent imaging. 3. Subject is willing and able to provide informed consent. 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. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 2. Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) = 2.5 × upper limit normal (ULN) 3. Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) = 2.5 × upper limit normal (ULN). |
Country | Name | City | State |
---|---|---|---|
United States | St. David's Surgical Hospital | Austin | Texas |
United States | OhioHealth | Columbus | Ohio |
United States | The Ohio State Unversity | Columbus | Ohio |
United States | The Hospital of Providence Transmountain Campus | El Paso | Texas |
United States | E.W. Sparrow Hospital | Lansing | Michigan |
United States | MountainView Hospital | Las Vegas | Nevada |
United States | HCA Mercy Hospital | Miami | Florida |
United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
United States | Orlando Health | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
Intuitive Surgical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 after second injection | Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes | 10 minutes | |
Other | 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 after second injection | Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes | 30 minutes | |
Other | 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 after second injection | Evaluate ureter visualization by independent reader at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging compared white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes | 45 minutes | |
Other | Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection | 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 after second injection for procedures lasting longer than 60 minutes | 10 minutes | |
Other | Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection | 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 after second injection for procedures lasting longer than 60 minutes. | 30 minutes | |
Other | Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection | 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 after second injection for procedures lasting longer than 60 minutes. | 45 minutes | |
Other | 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 - 2nd injection | Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes | 10 minutes | |
Other | 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 - 2nd injection | Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes | 30 minutes | |
Other | 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 - 2nd injection | Evaluate ureter visualization based on intraoperative surgeon's rating at (a) the pelvic brim and (b) uterine arteries in Firefly® imaging over white light mode after 2nd IS-001 injection for procedures lasting longer than 60 minutes | 45 minutes | |
Primary | 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 | 10 minutes | |
Primary | 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 | 30 minutes | |
Secondary | 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 | 10 | |
Secondary | 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 | 30 | |
Secondary | 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 | 10 minutes | |
Secondary | 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 30 minutes after IS-001 injection | 30 minutes | |
Secondary | 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 | 45 minutes | |
Secondary | 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 | 45 minutes | |
Secondary | 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 45 minutes after IS-001 injection | 45 minutes | |
Secondary | 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. | 10 minutes | |
Secondary | 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. | 30 minutes | |
Secondary | 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. | 45 minutes | |
Secondary | 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 | 10 minutes | |
Secondary | 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 | 30 minutes | |
Secondary | 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 | 45 minutes | |
Secondary | 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 | 10 minutes | |
Secondary | 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 | 30 minutes | |
Secondary | 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 | 45 minutes | |
Secondary | 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 | 10 minutes | |
Secondary | 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 | 30 minutes | |
Secondary | 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 | 45 minutes |
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