Ignite Creation Date:
2024-05-06 @ 9:38 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03039218
Status:
TERMINATED
Last Update Posted:
2018-08-17
First Post:
2017-01-26
Brief Title:
Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction ED
Sponsor:
Dornier MedTech Systems
Organization:
Dornier MedTech Systems
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Commercial decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None