ARIES for Vasculogenic Erectile Dysfunction

Completed · Phase 1

Conditions studied: Erectile Dysfunction, Sexual Dysfunction, Physiological

In brief

This study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of vasculogenic origin.

Key facts

Study ID

NCT02620982

Run by

Dornier MedTech Systems

People needed

23

Starts

2015-12-01

Expected to finish

2016-09-01

Last updated by the study team

2016-09-29

Who can join

Age: 21 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age 21 - 75 years
• Presence of Erectile Dysfunction for at least 6 months
• Having some response to a PDE5i or injection therapy (ICI) without penile scarring
• Vasculogenic ED
• IIEF-ED score ≥11 up to ≤25 while taking PDE5i or on ICI
• In a stable heterosexual relationship of more than three months' duration
• Agree to suspend all ED therapy for duration of study
• Agree to maintain their normal sexual habits
• Consent to participate

You may not qualify if…

• Radical prostatectomy
• Previous radiation therapy to pelvis
• Previous stem cell or platelet rich plasma therapy
• Previous pelvic surgeries
• Untreated Hypogonadism or thyroid disease
• Hormone usage, other than testosterone, clomiphene or thyroid medication
• Illicit drug usage as demonstrated in the drug screen
• Psychogenic ED
• Peyronie's Disease or penile curvature that negatively influences sexual activity
• Current anticoagulation therapy or significant hematological conditions

Where it is running

• San Diego Sexual Medicine — San Diego, California, United States

Full record on ClinicalTrials.gov

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