Clinical trial NCT05954767: IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ureter Injury
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 237
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 10 minutes
measure: 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
timeFrame: 30 minutes
Secondary outcomes:
measure: Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
timeFrame: 10
measure: Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
timeFrame: 30
measure: 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
timeFrame: 10 minutes
measure: 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
timeFrame: 30 minutes
measure: 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
timeFrame: 45 minutes
measure: Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
timeFrame: 45 minutes
measure: 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
timeFrame: 45 minutes
measure: Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
timeFrame: 10 minutes
measure: Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
timeFrame: 30 minutes
measure: Ureter signal-to-background ratio evaluating contrast of fluorescent signal in near infrared imaging mode
timeFrame: 45 minutes
measure: concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
timeFrame: 10 minutes
measure: concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
timeFrame: 30 minutes
measure: concordance between intra-operative ureter visualization assessment and independent reader ureter visualization assessment
timeFrame: 45 minutes
measure: Determine degree of concordance of ureter visualization between independent readers
timeFrame: 10 minutes
measure: Determine degree of concordance of ureter visualization between independent readers
timeFrame: 30 minutes
measure: Determine degree of concordance of ureter visualization between independent readers
timeFrame: 45 minutes
measure: degree of concordance of ureter visualization within independent readers
timeFrame: 10 minutes
measure: degree of concordance of ureter visualization within independent readers
timeFrame: 30 minutes
measure: degree of concordance of ureter visualization within independent readers
timeFrame: 45 minutes
Other outcomes:
measure: 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
timeFrame: 10 minutes
measure: 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
timeFrame: 30 minutes
measure: 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
timeFrame: 45 minutes
measure: Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection
timeFrame: 10 minutes
measure: Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection
timeFrame: 30 minutes
measure: Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length after second injection
timeFrame: 45 minutes
measure: 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
timeFrame: 10 minutes
measure: 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
timeFrame: 30 minutes
measure: 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
timeFrame: 45 minutes
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Miami
country: United States
facility: HCA Mercy Hospital
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Lansing
country: United States
facility: E.W. Sparrow Hospital
state: Michigan
city: Las Vegas
country: United States
facility: MountainView Hospital
state: Nevada
city: Columbus
country: United States
facility: The Ohio State Unversity
state: Ohio
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
city: Austin
country: United States
facility: St. David's Surgical Hospital
state: Texas
city: El Paso
country: United States
facility: The Hospital of Providence Transmountain Campus
state: Texas
Study officials:
References: