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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2025-09-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ureter Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Efficacy

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.

Group Type OTHER

IS-001

Intervention Type DRUG

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

Interventions

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IS-001

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No