Effect of Erchonia Laser on Erectile Dysfunction

Not Applicable

Withdrawn

• Conditions: Erectile Dysfunction
• Interventions: Device: Erchonia HLS

• Registration Number: NCT05371951
• Lead Sponsor: Erchonia Corporation

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.

Study Timeline

• Study Start: 2021-10-05
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-12
• Status Verified: 2023-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erchonia HLS	Erchonia HLS	635 nanometers (nm) laser application

Primary Outcome Measures

Name	Time	Method
Total Score on the International Index of Erectile Function - Erectile Function	6 week	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

Secondary Outcome Measures

Name	Time	Method
Total Erection Hardness Score	6 week	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

Trial Locations

Locations (1)

Ranjodh S. Gill, MD, FACP; 🇺🇸 Richmond, Virginia, United States