Effect of Erchonia Laser on Erectile Dysfunction

NCT05371951 | Withdrawn FDA Device

• 1 other identifier: R-ED
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Erection Hardness Score

  6 week

Study Arms (1)

Erchonia HLS

EXPERIMENTAL

635 nanometers (nm) laser application

Device: Erchonia HLS

Interventions

Erchonia HLS DEVICE

84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.

Erchonia HLS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Ranjodh S. Gill, MD, FACP

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 12, 2022
• Study Start: October 5, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)