Effect of Erchonia Laser on Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05371951
• Other study ID #: R-ED
• Status: Withdrawn
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	Ranjodh S. Gill, MD, FACP	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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