Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-10-05
2023-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Erchonia HLS
635 nanometers (nm) laser application
Erchonia HLS
84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.
Interventions
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Erchonia HLS
84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Known or suspected vasculogenic ED based on clinical history
* In an active sexual relationship with a minimum of 2 sexual attempts per month for at least one month prior to enrollment
* Suffering from ED for at least 6 months
* Testosterone level between 300 - 1000ng/dL within one month prior to enrollment
* Hgb A1C less than or equal to 8% within one month prior to enrollment
* Total IIEF-EF scores between 8-25
* EHS score greater than or equal to
Exclusion Criteria
* Men with known neurogenic or psychogenic ED
* Anatomic malformations of the penis including Peyronie's disease
* Testosterone greater than 300ng/dL or 1000ng/dL
* Hgb A1C greater than 8%
* International Normalized Ratio greater than 2.5, and men on any blood thinners other than 81mg aspirin
* Active testicular or prostate cancer
40 Years
80 Years
MALE
No
Sponsors
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Erchonia Corporation
INDUSTRY
Responsible Party
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Locations
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Ranjodh S. Gill, MD, FACP
Richmond, Virginia, United States
Countries
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Other Identifiers
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R-ED
Identifier Type: -
Identifier Source: org_study_id
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