NCT03006237CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Intuitive Surgical
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
Study Overview
Brief Summary
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject is between the ages of 18 and
- •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.
Arms & Interventions
IV IS-001 drug
Experimental
IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System
Intervention: IS-001 (Drug)
IV IS-001 drug
Experimental
IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System
Intervention: da Vinci® Si/Xi Surgical System (Device)
Outcomes
Primary Outcomes
Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
Time Frame: 14 days
Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events
Secondary Outcomes
- Evaluation of pharmacokinetic parameter of IS-001: Tmax(6 hours)
- Evaluation of pharmacokinetic parameter of IS-001: t1/2(6 hours)
- Evaluation of pharmacokinetic parameter of IS-001: Cmax(6 hours)
- Evaluation of pharmacokinetic parameter of IS-001: AUC(6 hours)
Investigators
Study Sites (1)
Loading locations...
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