<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/NCT02974751</url>
  </required_header>
  <id_info>
    <org_study_id>TP0118</org_study_id>
    <nct_id>NCT02974751</nct_id>
  </id_info>
  <brief_title>Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue</brief_title>
  <acronym>OPEN WATER</acronym>
  <official_title>Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PROCEPT BioRobotics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PROCEPT BioRobotics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the&#xD;
      treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia&#xD;
      (BPH).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Anticipated">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">May 24, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>IPSS score change</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">178</enrollment>
  <condition>BPH</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aquablation</intervention_name>
    <description>Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with lower urinary tract symptoms, including those with urinary retention, who&#xD;
        meet all other enrollment criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male.&#xD;
&#xD;
          -  Subject has diagnosis of lower urinary tract symptoms due to benign prostatic&#xD;
             enlargement causing bladder outlet obstruction or in urinary retention.&#xD;
&#xD;
          -  Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.&#xD;
&#xD;
          -  Patient is mentally capable and willing to sign a study-specific informed consent&#xD;
             form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal&#xD;
             anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior&#xD;
             to treatment per standard of care.&#xD;
&#xD;
          -  History of gross haematuria.&#xD;
&#xD;
          -  Participants using systemic immune-suppressants including corticosteroids (except&#xD;
             inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).&#xD;
&#xD;
          -  Contraindication to both general and spinal anesthesia.&#xD;
&#xD;
          -  Any severe illness that would prevent complete study participation or confound study&#xD;
             results.&#xD;
&#xD;
          -  Subject is unwilling to accept a transfusion should one be required.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinikum Harburg</name>
      <address>
        <city>Hamburg</city>
        <zip>21075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American University of Beirut Medical Center</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tauranga Urology Research</name>
      <address>
        <city>Tauranga</city>
        <zip>3112</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frimley Park Hospital</name>
      <address>
        <city>Frimley</city>
        <state>Surrey</state>
        <zip>GU16 7UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Germany</country>
    <country>Lebanon</country>
    <country>New Zealand</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aquablation</keyword>
  <keyword>AQUABEAM</keyword>
  <keyword>BPH</keyword>
  <keyword>LUTS</keyword>
  <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/NCT02974751
org study id: TP0118
nct id: NCT02974751
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the
      treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia
      (BPH).
observational model: Case-Only
time perspective: Prospective
measure: IPSS score change
time frame: 3 months
intervention type: Procedure
intervention name: Aquablation
description: Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Germany
country: Lebanon
country: New Zealand
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided