Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)
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|ClinicalTrials.gov Identifier: NCT03039218|
Recruitment Status : Terminated (Commercial decision)
First Posted : February 1, 2017
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Device: Dornier Aries 2 Device: Placebo / Sham||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||54 participants|
|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.|
|Masking:||Double (Participant, Investigator)|
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
|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)|
|Actual Study Start Date :||February 7, 2017|
|Actual Primary Completion Date :||March 29, 2018|
|Actual Study Completion Date :||March 29, 2018|
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
- 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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039218
|United States, California|
|San Diego Sexual Medicine|
|San Diego, California, United States, 92120|
|United States, Nebraska|
|Adult Pediatric Urology & Urogynecology|
|Omaha, Nebraska, United States, 68114|
|United States, New York|
|Brooklyn Urology Research Group|
|Brooklyn, New York, United States, 11215|
|Manhattan Medical Research|
|New York, New York, United States, 10016|
|Principal Investigator:||Irwin Goldstein||San Diego Sexual Medicine|