Erectile DysfunctionNCT05371951
Effect of Erchonia Laser on Erectile Dysfunction
A study testing Erchonia HLS in people with Erectile Dysfunction, run by Erchonia Corporation at 1 site in United States.
Trial summary
This study is to see if applying low-level laser light can provide improvement in erectile dysfunction Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Erchonia HLS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Erchonia HLS
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia HLSDevice
84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia HLS | Experimental | 635 nanometers (nm) laser application Receives: Device: Erchonia HLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 week
Secondary outcomes (1)
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
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start5 Oct 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Why it stopped: Difficulty in study subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371951
- Sponsor's protocol ID
- R-ED
- Status last verified
- Mar 2023
- First submitted
- 4 May 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of the Effect of the Erchonia® HLS™ on Individuals With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05371951
- Acronym / sponsor ID
- R-ED
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in study subject recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia HLS | Experimental | Device: Erchonia HLS635 nanometers (nm) laser application |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia HLS84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks. | Device | Erchonia HLS |
Primary outcome
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
1 secondary outcome
Total Erection Hardness Score
Time frame: 6 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia HLS in people with Erectile Dysfunction, run by Erchonia Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score on the International Index of Erectile Function - Erectile Function (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.