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Effect of Erchonia Laser on Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia HLS
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Ranjodh S. Gill, MD, FACP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erchonia HLS

Arm Description

635 nanometers (nm) laser application

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2022
Last Updated
March 21, 2023
Sponsor
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05371951
Brief Title
Effect of Erchonia Laser on Erectile Dysfunction
Official Title
A Pilot Evaluation of the Effect of the Erchonia® HLS™ on Individuals With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in study subject recruitment
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erchonia HLS
Arm Type
Experimental
Arm Description
635 nanometers (nm) laser application
Intervention Type
Device
Intervention Name(s)
Erchonia HLS
Intervention Description
84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.
Primary Outcome Measure Information:
Title
Total Score on the International Index of Erectile Function - Erectile Function
Description
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
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Total Erection Hardness Score
Description
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
Time Frame
6 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ranjodh S. Gill, MD, FACP
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Erchonia Laser on Erectile Dysfunction

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