Effect of Erchonia Laser on Erectile Dysfunction

Study Overview
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Brief Summary
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This study is to see if applying low-level laser light can provide improvement in erectile dysfunction

Detailed Description
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The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing improvement in erectile dysfunction.

Official Title
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A Pilot Evaluation of the Effect of the Erchonia® HLS™ on Individuals With Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Erchonia HLS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male between 40 and 80 years old 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: ED due to radical prostatectomy, prior pelvic surgery, or radiation therapy to the pelvis within 12 months prior to enrollment 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erchonia HLS<br>635 nanometers (nm) laser application | Device: Erchonia HLS<br>* 84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Score on the International Index of Erectile Function - Erectile Function | The International Index of Erectile Function - Erectile Function ( domain score is a patient questionnaire (six questions) used to measure various aspects of erectile performance and assess disease severity in efficacy trials concerning ED. The International Index of Erectile Function - Erectile Function has a minimum score of 0 and max of 30, higher scores mean a better outcome | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Erection Hardness Score | The Erection Hardness Score is a single-item scale that has demonstrated good psychometric properties for assessing erectile function in patients. The EHS has desirable measurement properties, including being highly responsive to treatment. This one-item PRO is robust and easy to use for evaluating erection hardness. The Total Erection Hardness Score has a minimum possible score of 0 and max of 4, higher scores mean a better outcome | 6 week |