Effect of Erchonia Laser on Erectile Dysfunction

Erchonia

Status

Withdrawn

Conditions

Erectile Dysfunction

Treatments

Device: Erchonia HLS

Study type

Interventional

Funder types

Industry

Identifiers

NCT05371951

R-ED

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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