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

NCT03039218 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-08-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Dornier MedTech Systems

    lead INDUSTRY

Principal Investigators

  • Irwin Goldstein · San Diego Sexual Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-07
Primary Completion
2018-03-29
Completion
2018-03-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03039218 on ClinicalTrials.gov