Effect of Erchonia Laser on Erectile Dysfunction

March 21, 2023 updated by: Erchonia Corporation

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Ranjodh S. Gill, MD, FACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erchonia HLS
635 nanometers (nm) laser application
Device: Erchonia HLS
84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Score on the International Index of Erectile Function - Erectile Function
Time Frame: 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
6 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Erection Hardness Score
Time Frame: 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
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erchonia Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-ED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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