<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03006237</url>
  </required_header>
  <id_info>
    <org_study_id>ISI-001-01</org_study_id>
    <nct_id>NCT03006237</nct_id>
  </id_info>
  <brief_title>IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intuitive Surgical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001&#xD;
      Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical&#xD;
      System with Firefly® Fluorescent Imaging&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)</measure>
    <time_frame>14 days</time_frame>
    <description>Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pharmacokinetic parameter of IS-001: Cmax</measure>
    <time_frame>6 hours</time_frame>
    <description>Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pharmacokinetic parameter of IS-001: Tmax</measure>
    <time_frame>6 hours</time_frame>
    <description>Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pharmacokinetic parameter of IS-001: t1/2</measure>
    <time_frame>6 hours</time_frame>
    <description>Pharmacokinetics for IS-001 as measured by terminal elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pharmacokinetic parameter of IS-001: AUC</measure>
    <time_frame>6 hours</time_frame>
    <description>Pharmacokinetics for IS-001 as measured by area under the serum/drug concentration time curve</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hysterectomy</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>IV IS-001 drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IS-001</intervention_name>
    <description>10mg, 20mg or 40 mg IV IS-001 drug administered during surgery</description>
    <arm_group_label>IV IS-001 drug</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>da Vinci® Si/Xi Surgical System</intervention_name>
    <description>robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging</description>
    <arm_group_label>IV IS-001 drug</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is between the ages of 18 and 65.&#xD;
&#xD;
          2. Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical&#xD;
             system with Firefly® fluorescent imaging.&#xD;
&#xD;
          3. Subject is willing and able to provide informed consent.&#xD;
&#xD;
          4. Subject is considered capable of complying with study procedures.&#xD;
&#xD;
          5. Subject has no medical history of liver or kidney disease.&#xD;
&#xD;
          6. Subject has no evidence of NYHA Class II-IV cardiac disease.&#xD;
&#xD;
          7. Subject has recent (&lt; 3 months) clinical hematology (CBC) values within the acceptable&#xD;
             values reference range.&#xD;
&#xD;
          8. Subject has recent (&lt; 3 months) clinical serum chemistry (CMP) values within the&#xD;
             acceptable values reference range.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is pregnant or nursing.&#xD;
&#xD;
          2. Subject has a history of alcoholism.&#xD;
&#xD;
          3. Subject has a history of drug abuse.&#xD;
&#xD;
          4. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.&#xD;
&#xD;
          5. Subject has known human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          6. Subject has been diagnosed with or treated for cancer in the last 2 years.&#xD;
&#xD;
          7. Subject has a total body weight &lt; 32 kg.&#xD;
&#xD;
          8. Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or&#xD;
             a systolic blood pressure ≥160 mmHg.&#xD;
&#xD;
          9. Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm.&#xD;
&#xD;
         10. Subject has any other condition or personal circumstance that, in the judgment of the&#xD;
             investigator, might interfere with the collection of complete good quality data or&#xD;
             represents an unacceptable safety liability.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Farnam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Las Palmas Medical Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>March 1, 2018</last_update_submitted>
  <last_update_submitted_qc>March 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03006237
org study id: ISI-001-01
nct id: NCT03006237
lead sponsor: 
has dmc: No
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
time frame: 14 days
description: Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events
measure: Evaluation of pharmacokinetic parameter of IS-001: Cmax
time frame: 6 hours
description: Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration
measure: Evaluation of pharmacokinetic parameter of IS-001: Tmax
time frame: 6 hours
description: Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration
measure: Evaluation of pharmacokinetic parameter of IS-001: t1/2
time frame: 6 hours
description: Pharmacokinetics for IS-001 as measured by terminal elimination half-life
measure: Evaluation of pharmacokinetic parameter of IS-001: AUC
time frame: 6 hours
description: Pharmacokinetics for IS-001 as measured by area under the serum/drug concentration time curve
arm group label: IV IS-001 drug
arm group type: Experimental
description: IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System
intervention type: Drug
intervention name: IS-001
description: 10mg, 20mg or 40 mg IV IS-001 drug administered during surgery
arm group label: IV IS-001 drug
intervention type: Device
intervention name: da Vinci® Si/Xi Surgical System
description: robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
arm group label: IV IS-001 drug
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Farnam, MD
role: Principal Investigator
affiliation: Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided