IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics

Intuitive Surgical

Status and phase

Completed

Phase 1

Conditions

Surgery

Hysterectomy

Treatments

Device: da Vinci® Si/Xi Surgical System

Drug: IS-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT03006237

ISI-001-01

Details and patient eligibility

About

A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001

Full description

A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging

Enrollment

24 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is between the ages of 18 and 65.
Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging.
Subject is willing and able to provide informed consent.
Subject is considered capable of complying with study procedures.
Subject has no medical history of liver or kidney disease.
Subject has no evidence of NYHA Class II-IV cardiac disease.
Subject has recent (< 3 months) clinical hematology (CBC) values within the acceptable values reference range.
Subject has recent (< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range.

Exclusion criteria

Subject is pregnant or nursing.
Subject has a history of alcoholism.
Subject has a history of drug abuse.
Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Subject has known human immunodeficiency virus (HIV) infection.
Subject has been diagnosed with or treated for cancer in the last 2 years.
Subject has a total body weight < 32 kg.
Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg.
Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm.
Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data or represents an unacceptable safety liability.