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CompletedNCT03006237Updated Mar 5, 2018

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

A Phase 1 interventional study of IS-001 and da Vinci® Si/Xi Surgical System in Hysterectomy and Surgery, sponsored by Intuitive Surgical. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Intuitive Surgical · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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

Read the 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

02

Conditions studied

  • Hysterectomy
  • Surgery
03

In context

Lead sponsor

Intuitive Surgical is the lead sponsor of 62 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    IV IS-001 drug

    IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System

    Drug: IS-001 · Device: da Vinci® Si/Xi Surgical System

Interventions

  • DrugIS-001

    10mg, 20mg or 40 mg IV IS-001 drug administered during surgery

  • Deviceda Vinci® Si/Xi Surgical System

    robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging

06

What researchers measure

Primary outcomes

  1. Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)

    Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events

    Time frame: 14 days

Secondary outcomes

  1. Evaluation of pharmacokinetic parameter of IS-001: Cmax

    Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration

    Time frame: 6 hours

  2. Evaluation of pharmacokinetic parameter of IS-001: Tmax

    Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration

    Time frame: 6 hours

  3. Evaluation of pharmacokinetic parameter of IS-001: t1/2

    Pharmacokinetics for IS-001 as measured by terminal elimination half-life

    Time frame: 6 hours

  4. Evaluation of pharmacokinetic parameter of IS-001: AUC

    Pharmacokinetics for IS-001 as measured by area under the serum/drug concentration time curve

    Time frame: 6 hours

07

Study locations

1 site
  • Las Palmas Medical Center
    El Paso, Texas 79902, United States
08

References and documents

Publications

  • 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. PubMed 31215195 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03006237
Lead sponsor
Intuitive Surgical
Responsible party
Sponsor
First posted
Dec 30, 2016
Start date
Dec 2016
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Mar 5, 2018

Study contacts

Richard Farnam, MD
principal investigator · Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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