Clinical trial NCT03006237: IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hysterectomy
Surgery
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2016-12-30
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subject is pregnant or nursing.
2. Subject has a history of alcoholism.
3. Subject has a history of drug abuse.
4. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
5. Subject has known human immunodeficiency virus (HIV) infection.
6. Subject has been diagnosed with or treated for cancer in the last 2 years.
7. Subject has a total body weight \< 32 kg.
8. Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg.
9. Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm.
10. 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.

Primary outcomes:
measure: Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
timeFrame: 14 days
Secondary outcomes:
measure: Evaluation of pharmacokinetic parameter of IS-001: Cmax
timeFrame: 6 hours
measure: Evaluation of pharmacokinetic parameter of IS-001: Tmax
timeFrame: 6 hours
measure: Evaluation of pharmacokinetic parameter of IS-001: t1/2
timeFrame: 6 hours
measure: Evaluation of pharmacokinetic parameter of IS-001: AUC
timeFrame: 6 hours
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Las Palmas Medical Center
state: Texas
Study officials:
affiliation: Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center
name: Richard Farnam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farnam RW, Arms RG, Klaassen AH, Sorger JM. Intraoperative ureter visualization using a near-infrared imaging agent. J Biomed Opt. 2019 Jun;24(6):1-8. doi: 10.1117/1.JBO.24.6.066004.