<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/NCT01732991</url>
  </required_header>
  <id_info>
    <org_study_id>PHAO 2012 - FB / PROPIL</org_study_id>
    <nct_id>NCT01732991</nct_id>
  </id_info>
  <brief_title>Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound</brief_title>
  <acronym>PROPIL</acronym>
  <official_title>Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the&#xD;
      treatment of benign prostatic hypertrophy (BPH) as recommended.&#xD;
&#xD;
      The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The&#xD;
      underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal&#xD;
      effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced&#xD;
      ultrasound the necrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The laser PVP with an optical fiber firing side carries out a vaporization of next prostatic&#xD;
      tissue and a necrosis of underlying prostatic tissue which corresponds to a postoperative&#xD;
      inflammatory area.&#xD;
&#xD;
      One of the side effects of this technique is the irritative syndrome which may involve&#xD;
      urinary frequency, urgency or burning urination in approximately 10 to 20% at 1 month.&#xD;
&#xD;
      The current literature does report neither the analysis of the underlying inflammatory&#xD;
      necrotic area in prostatic vaporized tissue, nor the analysis of the urinary irritative signs&#xD;
      post-laser PVP.&#xD;
&#xD;
      Progresses in the field of functional ultrasound imaging allow us to consider a study of&#xD;
      evolution of the underlying necrotic area devoid of micro-vascularisation under effect of PVP&#xD;
      laser. The parallel with results of MRI (radiological technique most referenced) during the&#xD;
      same period would help to support the experimental results of prostatic contrast-enhanced&#xD;
      ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of thickness of the average necrotic area</measure>
    <time_frame>J0 (immediately after surgery) M1, M6 and M12</time_frame>
    <description>The primary outcome measure is the measurement of the thickness of the average necrotic area in millimeters on prostatic monitoring MRI and contrast-enhanced ultrasound (no hypothesis in this descriptive study). The variables will be collected immediately after surgery as well as M1, M6 and M12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of urinary irritative signs over 12 months</measure>
    <time_frame>J0, M1, M6 and M12</time_frame>
    <description>Evolution of urinary irritative signs over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound): score of IPSS questionary, results of the examination (binary variable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of prostatic volume over 12 months</measure>
    <time_frame>J0, M1, M6 and M12</time_frame>
    <description>Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Prostatic Hypertrophy, Benign</condition>
  <arm_group>
    <arm_group_label>prostatic photo-vaporization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>prostatic photo-vaporization (PVP) surgery with laser Greenlight</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>prostatic photo-vaporization (PVP)</intervention_name>
    <description>Prostatic photo-vaporization using a lithium laser of 532nm wavelength (GREEN-LIGHT XPS™,American Medical Systems, Minnetonka, MN, USA) emitting by a fiber MoXy™ a maximum power of 180 W continuously. Using common practice and according to the CE labelling.</description>
    <arm_group_label>prostatic photo-vaporization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 40 years old without an upper age limit&#xD;
&#xD;
          -  Informed orally and in writing, having signed a consent which match to the research&#xD;
&#xD;
          -  Patient with a benign prostatic hypertrophy requiring surgical treatment by PVP&#xD;
&#xD;
          -  Person affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to MRI for patients with:&#xD;
&#xD;
               -  ocular metallic foreign object&#xD;
&#xD;
               -  any electronic medical device implanted by irremovable way (pacemakers,&#xD;
                  neuro-stimulator, cochlear implants ...)&#xD;
&#xD;
               -  metallic heart valve, old heart valves are specially an absolute contraindication&#xD;
                  because of risk of dysfunction&#xD;
&#xD;
               -  vascular clips implanted formerly on brain aneurysm&#xD;
&#xD;
          -  Allergy to Gadolinium&#xD;
&#xD;
          -  Contraindications to the contrast medium Sonovue:&#xD;
&#xD;
               -  Hypersensitivity to hexafluorinated sulphur or any other components of Sonovue&#xD;
&#xD;
               -  Recent acute coronary syndrome (within 6 months before the intervention)&#xD;
&#xD;
               -  Unstable ischemic heart disease (myocardial infarction being formed or evolving,&#xD;
                  typical angina of rest in the previous month)&#xD;
&#xD;
               -  Significant worsening of cardiac symptoms between the pre anaesthesia&#xD;
                  consultation and intervention&#xD;
&#xD;
               -  Recent intervention (less than 6 months) on coronary arteries or other factor&#xD;
                  suggesting clinical instability (changes in ECG, changes in clinical or&#xD;
                  biological parameters)&#xD;
&#xD;
               -  Acute heart failure or heart failure stage III or IV&#xD;
&#xD;
               -  Severe arrhythmias&#xD;
&#xD;
               -  Right-left shunt&#xD;
&#xD;
               -  Acute endocarditis&#xD;
&#xD;
               -  Valve prothesis&#xD;
&#xD;
               -  Severe pulmonary hypertension (pulmonary artery pressure &gt; 90mmHg)&#xD;
&#xD;
               -  Systemic hypertension uncontrolled&#xD;
&#xD;
               -  Respiratory distress syndrome&#xD;
&#xD;
          -  Prostatic biopsy &lt; 30 days or anal pathology&#xD;
&#xD;
          -  Patient with prostate cancer&#xD;
&#xD;
          -  Patient with a urinary infection&#xD;
&#xD;
          -  Patient with preoperative urinary catheter&#xD;
&#xD;
          -  Patient with a contraindication for surgery&#xD;
&#xD;
          -  Adult patient with a legal protection measure&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franck BRUYERE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU TOURS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chru Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>August 31, 2015</last_update_submitted>
  <last_update_submitted_qc>August 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostatic Hypertrophy, Benign</keyword>
  <keyword>Greenlight laser</keyword>
  <keyword>Prostatic photovaporization</keyword>
  <keyword>Prostatic MRI</keyword>
  <keyword>Prostatic contrast-enhanced ultrasound</keyword>
  <keyword>Urinary irritative signs</keyword>
  <keyword>Postoperative necrotic area</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <!-- 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/NCT01732991
org study id: PHAO 2012 - FB / PROPIL
nct id: NCT01732991
lead sponsor: 
has dmc: No
The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the
      treatment of benign prostatic hypertrophy (BPH) as recommended.

      The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The
      underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal
      effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced
      ultrasound the necrosis.
The laser PVP with an optical fiber firing side carries out a vaporization of next prostatic
      tissue and a necrosis of underlying prostatic tissue which corresponds to a postoperative
      inflammatory area.

      One of the side effects of this technique is the irritative syndrome which may involve
      urinary frequency, urgency or burning urination in approximately 10 to 20% at 1 month.

      The current literature does report neither the analysis of the underlying inflammatory
      necrotic area in prostatic vaporized tissue, nor the analysis of the urinary irritative signs
      post-laser PVP.

      Progresses in the field of functional ultrasound imaging allow us to consider a study of
      evolution of the underlying necrotic area devoid of micro-vascularisation under effect of PVP
      laser. The parallel with results of MRI (radiological technique most referenced) during the
      same period would help to support the experimental results of prostatic contrast-enhanced
      ultrasound.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evolution of thickness of the average necrotic area
time frame: J0 (immediately after surgery) M1, M6 and M12
description: The primary outcome measure is the measurement of the thickness of the average necrotic area in millimeters on prostatic monitoring MRI and contrast-enhanced ultrasound (no hypothesis in this descriptive study). The variables will be collected immediately after surgery as well as M1, M6 and M12.
measure: Evolution of urinary irritative signs over 12 months
time frame: J0, M1, M6 and M12
description: Evolution of urinary irritative signs over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound): score of IPSS questionary, results of the examination (binary variable)
measure: Evolution of prostatic volume over 12 months
time frame: J0, M1, M6 and M12
description: Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)
arm group label: prostatic photo-vaporization
arm group type: Experimental
description: prostatic photo-vaporization (PVP) surgery with laser Greenlight
intervention type: Device
intervention name: prostatic photo-vaporization (PVP)
description: Prostatic photo-vaporization using a lithium laser of 532nm wavelength (GREEN-LIGHT XPS™,American Medical Systems, Minnetonka, MN, USA) emitting by a fiber MoXy™ a maximum power of 180 W continuously. Using common practice and according to the CE labelling.
arm group label: prostatic photo-vaporization
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Franck BRUYERE, MD
role: Principal Investigator
affiliation: CHRU TOURS
facility: 
country: France
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hypertrophy