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NCT03067987 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT03067987 is a NA study that has completed, run by University of Miami. The registered enrollment target is 103 participants.
The verdict
NCT03067987, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study Summary
Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves 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 erectile dysfunction. HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a \>2-point increase in the IIEF-EF score from baseline for mild erectile dysfunction, and \>5 points for moderate erectile dysfunction and will show significant change. Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment groups for alleviating erectile dysfunction measured using International Index of Erectile Function score (IIEF-EF). Primary Efficacy Objective: To evaluate change of International Index of Erectile Function score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment. Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to: * SEP- Sexual Encounter Profile Questionnaire. * GAQ- Global Assessment Questionnaire. * EHS- Erection Hardness Score.
Interventions
- DEVICE Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2017-02-22 |
| Est. Completion | 2019-05-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03067987
The ClinicalTrials.gov registry entry for NCT03067987 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. is the first listed.
NCT03067987 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03067987 about?
NCT03067987 is a clinical study titled "Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction". Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and eff...
What is the current status of trial NCT03067987?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2017-02-22. Estimated completion is 2019-05-28.
What interventions are being tested in trial NCT03067987?
The interventions under investigation include: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. (DEVICE).
Who is sponsoring clinical trial NCT03067987?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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