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

NCT05954767 | Completed Phase 3 FDA Drug

• 1 other identifier: ISI-124804-3
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Ureter Injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (19)

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

  10

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

  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

  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

  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

  45 minutes

Other Outcomes (9)

• 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

  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 after second injection

  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 after second injection

  45 minutes

Study Arms (1)

Efficacy

OTHER

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.

Drug: IS-001

Interventions

IS-001 DRUG

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

Efficacy

Eligibility Criteria

• Age: 16 Years - 75 Years
• Gender Eligibility Details: biological
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subject is between the ages of 16 and 75, inclusive at time of consent.
• Subject is scheduled to undergo robotic-assisted gynecological procedure using a da Vinci® Surgical System with Firefly® Fluorescence Imaging.
• Subject and/or subject's parent/guardian is willing and able to provide informed consent and/or assent as applicable.

You may not qualify if:

• Subject is pregnant or nursing.
• Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• 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
• Subject has a known or suspected hypersensitivity to indocyanine green (ICG)
• Subject has any of the following screening laboratory values:
• eGFR \< 60 mL/min/1.73 m\^2
• Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) ≥ 2.5 × ULN
• Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 2.5 × ULN.
• Planned use of CYTALUX™ (pafolacianine) for surgery

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (8)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

HCA Mercy Hospital

Miami, Florida, 33133, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

E.W. Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

MountainView Hospital

Las Vegas, Nevada, 89128, United States

Location

The Ohio State Unversity

Columbus, Ohio, 43210, United States

Location

OhioHealth

Columbus, Ohio, 43214, United States

Location

St. David's Surgical Hospital

Austin, Texas, 78681, United States

Location

MeSH Terms

Interventions

IS 001

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: July 20, 2023
• Study Start: January 17, 2024
• Primary Completion: January 31, 2025
• Study Completion: September 29, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-09

Locations

US (8)