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

Launched by INTUITIVE SURGICAL · Jul 13, 2023

Keywords

ClinConnect Summary

This clinical trial, called IS-001 Injection, is looking at a new treatment to help doctors see the ureter (a tube that carries urine from the kidneys to the bladder) more clearly during robotic-assisted gynecological surgery. The study is testing an injection called IS-001, which will be given through an IV (intravenously) to see if it makes identifying the ureter easier and safer during the operation.

To participate in this trial, women between the ages of 18 and 75 who are scheduled for a specific type of surgery using a special robotic system may be eligible. It's important for participants to be in good health and not have certain conditions, like active liver infections or a severe allergy to a dye used in the study. If you join the trial, you can expect to be closely monitored by the medical team to ensure your safety and to gather important information about the treatment's effectiveness. This study is currently recruiting participants, so if you or someone you know is interested, it might be a good opportunity to discuss with a healthcare provider.

Gender

FEMALE

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).