<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/NCT03039218</url>
  </required_header>
  <id_info>
    <org_study_id>G140216 S004</org_study_id>
    <nct_id>NCT03039218</nct_id>
  </id_info>
  <brief_title>Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Open-Label Extension Clinical Trial of the Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dornier MedTech Systems</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dornier MedTech Systems</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of&#xD;
      22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile&#xD;
      dysfunction of at least 6 months duration with low intensity extracorporeal shock wave&#xD;
      therapy utilizing the Dornier Aries 2 device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective, randomized, placebo-controlled, double-blind pivotal study, with&#xD;
      an open-label extension. The study will include 4 sites and multiple investigators. A total&#xD;
      of 100 men with at least a 6-month history of ED and who have responded to PDE5 inhibitors&#xD;
      will be enrolled. The trial comprises two arms to achieve equal characteristics, where&#xD;
      patients are randomly assigned to active treatment or sham treatment.&#xD;
&#xD;
      All patients on active treatment will receive LI-ESWT treatment using the Dornier Aries 2.&#xD;
      Patients assigned to the placebo group will receive the Dornier Aries 2 treatment using a&#xD;
      sham applicator. The time between two treatments is 6-7 days to allow for angiogenesis and&#xD;
      perfusion improvements to occur. The subjects' duration of participation will be a total of&#xD;
      34 weeks Subjects will also be asked to maintain their current level of sexual activity while&#xD;
      participating in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Commercial decision&#xD;
  </why_stopped>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Actual">March 29, 2018</completion_date>
  <primary_completion_date type="Actual">March 29, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A total of 100 subjects will be randomized to either the Active or Sham/Placebo group. Following completion of the 3 month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/Sham treatment will be offered treatment using the Active device applicator.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Study subjects will be randomized in a 2:1 ratio to either active treatment or the control. The investigator and his staff do not know which applicator is the sham/placebo control and which are the active applicators. For the active treatment, a regular EMSE shockwave applicator will be used. The treatment group is further split into two equal groups, with both groups receiving the identical active treatment. In order to preserve the blinding of the investigator, the treatment devices are provided with two applicators (one for each of the active treatment groups), which while identical in function, differ slightly in appearance.&#xD;
For the sham treatment, a placebo applicator, including an absorber without emitting shockwaves, will be used. However, all three applicators (two to use with the active device and one with the sham) are going to produce exactly the typical shock wave sound with equivalent noise to reduce or eliminate bias from the investigator</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>International Inventory of Erectile Function (&quot;IIEF&quot;)</measure>
    <time_frame>primary outcome at 3 month follow-up visit</time_frame>
    <description>validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials</description>
  </primary_outcome>
  <other_outcome>
    <measure>Erectile Hardness Score</measure>
    <time_frame>Proportion of patients with an EHS=4 at the 3 month follow-up visit</time_frame>
    <description>tool to evaluate erectile dysfunction (ED) - a man's inability to get or maintain an erection firm enough for sex.</description>
  </other_outcome>
  <other_outcome>
    <measure>Global Assessment Questionnaire (&quot;GAQ&quot;).</measure>
    <time_frame>The proportion of subjects that answer the GAQ positively through the 3 month follow-up visit</time_frame>
    <description>2 question questionnaire that assesses improvement in symptoms following treatment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects assigned to this group will receive Active treatments using the Dornier Aries 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo / Sham</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects assigned to this group will receive placebo / sham (no active treatment).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dornier Aries 2</intervention_name>
    <description>Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo / Sham</intervention_name>
    <description>Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction</description>
    <arm_group_label>Placebo / Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Consent to participate.&#xD;
&#xD;
          2. Age 22-70 years.&#xD;
&#xD;
          3. Presence of Vasculogenic Erectile Dysfunction for at least 6 months.&#xD;
&#xD;
          4. Having some response to a PDE5i. Last PDE5i use must be within 30 days of Screening&#xD;
             Visit.&#xD;
&#xD;
          5. IIEF-EF score ≥17 up to ≤30 while taking PDE5i.&#xD;
&#xD;
          6. IIEF-EF score ≥17 up to ≤25 after wash out of PDE5i.&#xD;
&#xD;
          7. In a stable heterosexual relationship of more than three months duration.&#xD;
&#xD;
          8. Sexually active and agree to suspend all ED therapy for duration of study.&#xD;
&#xD;
          9. Agree to maintain their normal sexual habits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Radical prostatectomy.&#xD;
&#xD;
          2. Previous radiation therapy to pelvis.&#xD;
&#xD;
          3. Previous stem cell or platelet rich plasma therapy.&#xD;
&#xD;
          4. Previous pelvic surgeries that in the judgment of the investigator could impact on&#xD;
             erectile function such as radical prostatectomy, radical cystectomy, Peyronie's&#xD;
             disease surgery, penile lengthening or penile cancer surgery.&#xD;
&#xD;
          5. Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300&#xD;
             ng/dL.&#xD;
&#xD;
          6. Hormone usage, other than testosterone, clomiphene or thyroid medication.&#xD;
&#xD;
          7. Use of cocaine, cannabinoids, opiates, barbiturates, amphetamines, or benzodiazepine&#xD;
             as demonstrated in the drug screen.&#xD;
&#xD;
          8. Psychogenic ED.&#xD;
&#xD;
          9. Peyronie's Disease or penile curvature that negatively influences sexual activity.&#xD;
&#xD;
         10. Current anticoagulation therapy or significant hematological conditions as&#xD;
             demonstrated in abnormal values in the complete blood count.&#xD;
&#xD;
         11. Liver disease as demonstrated by abnormal chemistry panel or coagulation values in the&#xD;
             prothrombin time (PT) along with its derived measures of prothrombin ratio (PR) blood&#xD;
             tests.&#xD;
&#xD;
         12. Abnormal serum testosterone level defined as a value lower than 300 ng/dL or greater&#xD;
             than 1197 ng/dL.&#xD;
&#xD;
         13. Patients with cardiac or non-cardiac electrical devices implanted.&#xD;
&#xD;
         14. Anatomical or neurological abnormalities in the treatment area.&#xD;
&#xD;
         15. Diabetes Mellitus with severe polyneuropathy.&#xD;
&#xD;
         16. Patients with generalized polyneuropathy irrespective of cause.&#xD;
&#xD;
         17. Refusal to suspend ED therapy for duration of study.&#xD;
&#xD;
         18. Men deemed not healthy enough to participate in sexual activity.&#xD;
&#xD;
         19. IIEF-EF score of 0-16 or higher than 25 at baseline assessment following &quot;washout&quot;&#xD;
             period.&#xD;
&#xD;
         20. Average EHS ≤ 2 at baseline assessment following &quot;washout&quot;.&#xD;
&#xD;
         21. Any condition or behavior that indicates to the Principal Investigator that the&#xD;
             subject is unlikely to be compliant with study procedures and visits.&#xD;
&#xD;
         22. Any health history or laboratory result that indicates to the Principal Investigator&#xD;
             that the subject has a significant medical condition and should not participate in the&#xD;
             study.&#xD;
&#xD;
         23. Known allergy to ultrasound gel.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This study is for males with erectile dysfunction</gender_description>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irwin Goldstein</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego Sexual Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Diego Sexual Medicine</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adult Pediatric Urology &amp; Urogynecology</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooklyn Urology Research Group</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.</citation>
    <PMID>27986492</PMID>
  </results_reference>
  <results_reference>
    <citation>Angulo JC, Arance I, de Las Heras MM, Meilan E, Esquinas C, Andres EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2017 Oct;41(8):479-490. doi: 10.1016/j.acuro.2016.07.005. Epub 2016 Aug 10. English, Spanish.</citation>
    <PMID>27521134</PMID>
  </results_reference>
  <results_reference>
    <citation>Zou ZJ, Liu ZH, Tang LY, Lu YP. Is there a role for extracorporeal shock wave therapy for erectile dysfunction unresponsive to phosphodiesterase type 5 inhibitors? World J Urol. 2017 Jan;35(1):167-171. doi: 10.1007/s00345-016-1899-y. Epub 2016 Jul 22. No abstract available.</citation>
    <PMID>27447990</PMID>
  </results_reference>
  <results_reference>
    <citation>Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16.</citation>
    <PMID>27321373</PMID>
  </results_reference>
  <results_reference>
    <citation>Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y. Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study. J Urol. 2016 May;195(5):1550-1555. doi: 10.1016/j.juro.2015.12.049. Epub 2015 Dec 13.</citation>
    <PMID>26694904</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>August 15, 2018</last_update_submitted>
  <last_update_submitted_qc>August 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>erectile dysfunction</keyword>
  <keyword>shockwave</keyword>
  <keyword>Dornier</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual patient data will not be shared with other researchers.</ipd_description>
  </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/NCT03039218
org study id: G140216 S004
nct id: NCT03039218
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of
      22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile
      dysfunction of at least 6 months duration with low intensity extracorporeal shock wave
      therapy utilizing the Dornier Aries 2 device.
This trial is a prospective, randomized, placebo-controlled, double-blind pivotal study, with
      an open-label extension. The study will include 4 sites and multiple investigators. A total
      of 100 men with at least a 6-month history of ED and who have responded to PDE5 inhibitors
      will be enrolled. The trial comprises two arms to achieve equal characteristics, where
      patients are randomly assigned to active treatment or sham treatment.

      All patients on active treatment will receive LI-ESWT treatment using the Dornier Aries 2.
      Patients assigned to the placebo group will receive the Dornier Aries 2 treatment using a
      sham applicator. The time between two treatments is 6-7 days to allow for angiogenesis and
      perfusion improvements to occur. The subjects' duration of participation will be a total of
      34 weeks Subjects will also be asked to maintain their current level of sexual activity while
      participating in the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total of 100 subjects will be randomized to either the Active or Sham/Placebo group. Following completion of the 3 month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/Sham treatment will be offered treatment using the Active device applicator.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Study subjects will be randomized in a 2:1 ratio to either active treatment or the control. The investigator and his staff do not know which applicator is the sham/placebo control and which are the active applicators. For the active treatment, a regular EMSE shockwave applicator will be used. The treatment group is further split into two equal groups, with both groups receiving the identical active treatment. In order to preserve the blinding of the investigator, the treatment devices are provided with two applicators (one for each of the active treatment groups), which while identical in function, differ slightly in appearance.
For the sham treatment, a placebo applicator, including an absorber without emitting shockwaves, will be used. However, all three applicators (two to use with the active device and one with the sham) are going to produce exactly the typical shock wave sound with equivalent noise to reduce or eliminate bias from the investigator
measure: International Inventory of Erectile Function ("IIEF")
time frame: primary outcome at 3 month follow-up visit
description: validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials
measure: Erectile Hardness Score
time frame: Proportion of patients with an EHS=4 at the 3 month follow-up visit
description: tool to evaluate erectile dysfunction (ED) - a man's inability to get or maintain an erection firm enough for sex.
measure: Global Assessment Questionnaire ("GAQ").
time frame: The proportion of subjects that answer the GAQ positively through the 3 month follow-up visit
description: 2 question questionnaire that assesses improvement in symptoms following treatment
arm group label: Active
arm group type: Active Comparator
description: Subjects assigned to this group will receive Active treatments using the Dornier Aries 2.
arm group label: Placebo / Sham
arm group type: Placebo Comparator
description: Subjects assigned to this group will receive placebo / sham (no active treatment).
intervention type: Device
intervention name: Dornier Aries 2
description: Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
arm group label: Active
intervention type: Device
intervention name: Placebo / Sham
description: Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
arm group label: Placebo / Sham
criteria: 
gender: Male
gender based: Yes
gender description: This study is for males with erectile dysfunction
minimum age: 22 Years
maximum age: 70 Years
healthy volunteers: No
last name: Irwin Goldstein
role: Principal Investigator
affiliation: San Diego Sexual Medicine
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
PMID: 27986492
citation: Angulo JC, Arance I, de Las Heras MM, Meilan E, Esquinas C, Andres EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2017 Oct;41(8):479-490. doi: 10.1016/j.acuro.2016.07.005. Epub 2016 Aug 10. English, Spanish.
PMID: 27521134
citation: Zou ZJ, Liu ZH, Tang LY, Lu YP. Is there a role for extracorporeal shock wave therapy for erectile dysfunction unresponsive to phosphodiesterase type 5 inhibitors? World J Urol. 2017 Jan;35(1):167-171. doi: 10.1007/s00345-016-1899-y. Epub 2016 Jul 22. No abstract available.
PMID: 27447990
citation: Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017 Feb;71(2):223-233. doi: 10.1016/j.eururo.2016.05.050. Epub 2016 Jun 16.
PMID: 27321373
citation: Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y. Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study. J Urol. 2016 May;195(5):1550-1555. doi: 10.1016/j.juro.2015.12.049. Epub 2015 Dec 13.
PMID: 26694904
responsible party type: Sponsor
mesh term: Erectile Dysfunction
sharing ipd: No
ipd description: Individual patient data will not be shared with other researchers.