Status:
WITHDRAWN
Effect of Erchonia Laser on Erectile Dysfunction
Lead Sponsor:
Erchonia Corporation
Conditions:
Erectile Dysfunction
Eligibility:
MALE
40-80 years
Phase:
NA
Brief Summary
This study is to see if applying low-level laser light can provide improvement in erectile dysfunction
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05371951
Start Date
October 5 2021
End Date
March 1 2023
Last Update
March 23 2023
Active Locations (1)
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1
Ranjodh S. Gill, MD, FACP
Richmond, Virginia, United States, 23298