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Low Intensity Linear Shockwave Therapy for Erectile Dysfunction

NCT03843086 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-05-25

No results posted yet for this study

Summary

MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and effectiveness of this new type LISW in the relief of ED.

Conditions

  • Vasculogenic Erectile Dysfunction

Interventions

DEVICE

Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction

This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients using low intensity shockwave therapy. The patients are randomized in a 1:1 ratio into two active treatment groups. Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura). Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)

Sponsors & Collaborators

  • DIREX SYSTEMS CORPORATION

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Ryan P Smith, M.D. · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2022-03-31
Completion
2022-03-31

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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 NCT03843086 on ClinicalTrials.gov