Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)

August 15, 2018 updated by: Dornier MedTech Systems

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • San Diego Sexual Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Adult Pediatric Urology & Urogynecology
    • New York
      • Brooklyn, New York, United States, 11215
        • Brooklyn Urology Research Group
      • New York, New York, United States, 10016
        • Manhattan Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Consent to participate.
  2. Age 22-70 years.
  3. Presence of Vasculogenic Erectile Dysfunction for at least 6 months.
  4. Having some response to a PDE5i. Last PDE5i use must be within 30 days of Screening Visit.
  5. IIEF-EF score ≥17 up to ≤30 while taking PDE5i.
  6. IIEF-EF score ≥17 up to ≤25 after wash out of PDE5i.
  7. In a stable heterosexual relationship of more than three months duration.
  8. Sexually active and agree to suspend all ED therapy for duration of study.
  9. Agree to maintain their normal sexual habits.

Exclusion Criteria:

  1. Radical prostatectomy.
  2. Previous radiation therapy to pelvis.
  3. Previous stem cell or platelet rich plasma therapy.
  4. Previous pelvic surgeries that in the judgment of the investigator could impact on erectile function such as radical prostatectomy, radical cystectomy, Peyronie's disease surgery, penile lengthening or penile cancer surgery.
  5. Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300 ng/dL.
  6. Hormone usage, other than testosterone, clomiphene or thyroid medication.
  7. Use of cocaine, cannabinoids, opiates, barbiturates, amphetamines, or benzodiazepine as demonstrated in the drug screen.
  8. Psychogenic ED.
  9. Peyronie's Disease or penile curvature that negatively influences sexual activity.
  10. Current anticoagulation therapy or significant hematological conditions as demonstrated in abnormal values in the complete blood count.
  11. Liver disease as demonstrated by abnormal chemistry panel or coagulation values in the prothrombin time (PT) along with its derived measures of prothrombin ratio (PR) blood tests.
  12. Abnormal serum testosterone level defined as a value lower than 300 ng/dL or greater than 1197 ng/dL.
  13. Patients with cardiac or non-cardiac electrical devices implanted.
  14. Anatomical or neurological abnormalities in the treatment area.
  15. Diabetes Mellitus with severe polyneuropathy.
  16. Patients with generalized polyneuropathy irrespective of cause.
  17. Refusal to suspend ED therapy for duration of study.
  18. Men deemed not healthy enough to participate in sexual activity.
  19. IIEF-EF score of 0-16 or higher than 25 at baseline assessment following "washout" period.
  20. Average EHS ≤ 2 at baseline assessment following "washout".
  21. Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
  22. Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
  23. Known allergy to ultrasound gel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Subjects assigned to this group will receive Active treatments using the Dornier Aries 2.
Device: Dornier Aries 2
Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
Placebo Comparator: Placebo / Sham
Subjects assigned to this group will receive placebo / sham (no active treatment).
Device: Placebo / Sham
Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Inventory of Erectile Function ("IIEF")
Time Frame: primary outcome at 3 month follow-up visit
validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials
primary outcome at 3 month follow-up visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erectile Hardness Score
Time Frame: Proportion of patients with an EHS=4 at the 3 month follow-up visit
tool to evaluate erectile dysfunction (ED) - a man's inability to get or maintain an erection firm enough for sex.
Proportion of patients with an EHS=4 at the 3 month follow-up visit
Global Assessment Questionnaire ("GAQ").
Time Frame: The proportion of subjects that answer the GAQ positively through the 3 month follow-up visit
2 question questionnaire that assesses improvement in symptoms following treatment
The proportion of subjects that answer the GAQ positively through the 3 month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dornier MedTech Systems

Investigators

  • Principal Investigator: Irwin Goldstein, San Diego Sexual Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2017

Primary Completion (Actual)

March 29, 2018

Study Completion (Actual)

March 29, 2018

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G140216 S004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual patient data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erectile Dysfunction

Clinical Trials on Dornier Aries 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe