Effect of Erchonia Laser on Erectile Dysfunction

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    10
  • sponsor
    Erchonia Corporation
Updated on 29 May 2022
testosterone
testosterone level

Summary

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

Description

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.

Details
Condition Erectile Dysfunction
Treatment Erchonia HLS
Clinical Study IdentifierNCT05371951
SponsorErchonia Corporation
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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