Trials / Terminated
TerminatedNCT03039218
Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)
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)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Dornier MedTech Systems · Industry
- Sex
- Male
- Age
- 22 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dornier Aries 2 | Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction |
| DEVICE | Placebo / Sham | Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction |
Timeline
- Start date
- 2017-02-07
- Primary completion
- 2018-03-29
- Completion
- 2018-03-29
- First posted
- 2017-02-01
- Last updated
- 2018-08-17
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03039218. Inclusion in this directory is not an endorsement.