Erectile DysfunctionNCT06299332
Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction
A study testing Device treatment in people with Erectile Dysfunction, run by InMode MD Ltd. at 2 sites in United States.
Trial summary
The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED). 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?
- Device treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jun 2023to May 2025
- 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
- Adult male between ≥40 and ≤80 years of age
- Subjects with a history of self-reported erectile dysfunction lasting for over 6 months and not more than 5 years.
- The subject is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- The subject has been in a stable heterosexual relationship for over 3 months prior to enrollment.
- A minimum of 4 sexual attempts during the last two weeks prior to enrollment.
- Abstinence from taking PDE5 for two weeks (washout) after enrolment and 2 weeks before each follow up visit/call.
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- IIEF-EF score between 11 and 25.
- Testosterone level 300-1000 mg/dL within 1 month prior to the enrollment/baseline.
- A1C level ≤ 8.5% within 1 month prior to enrollemnt/baseline.
- Subject has at EHS score ≥ 1 (natural tumescence during sexual stimulation).
- The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and are willing to sign the Informed Consent Form
- If the FirmTech Ring is provided, the participants must be willing to use the ring according to the instructions.
- The subjects should be willing to comply with the study procedure and schedule, including follow up visits.
- Agreement/ability to abstain from erectile dysfunction medications or any device treatments for the duration of the study, i.e., the time between the treatment visit and the final study visit.
Who cannot join
- Evidence of co-existing Neurological disease or other systemic disease conditions such as Alzheimer or Parkinson disease which affects erectile function (at the discretion of the investigator)
- History of radical prostatectomy or extensive pelvic surgery ever
- Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
- Anatomical malformation of the penis, including Peyronie's disease.
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
- Diabetes type I
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- Diabetes Type II with A1C level > 8.5% within 1 month prior to enrollment.
- Unwillingness to abstain from systemic medications known to cause ED for the study duration.
- Internal defibrillator, pacemaker or any other implanted electrical device anywhere in the body
- Permanent metal implant in the treatment area
- Any surgery in the treatment area in the last 3 months
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles in the facial area
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction
- Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes and rash.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
- Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
- Use of Isotretinoin (Accutane®) within 30 days prior to treatment.
- Participation in another study within 30 days prior to screening.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
LC Medical 140 W 58th St, Suite A New York, NY 10019
New York, New York, 10019
Lanna Cheuck, 929-492-2052
- Recruiting
Washington Heights Urology
New York, New York, 10032
Robert Valenzuela, 212-781-9696
About this study
The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED).
- Conditions
- Erectile Dysfunction
- Being tested
- Device treatment
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device treatmentDevice
20 heterosexual males clinically diagnosed with Erectile Dysfunction will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit
| Study group | Role | What they receive |
|---|---|---|
| Device Treatment | Experimental | Eligible subjects will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit. Receives: Device: Device treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ED symptoms, following the RF treatment
Change in ED symptoms, following the RF treatment measured by THE INTERNATIONAL INDEX OF ERECTILE FUNCTION - ERECTILE FUNCTION (IIEF-EF) questionnaire score.
The IIEF-5 score is the sum of the ordinal responses to the 5 items.(1 to 5 ) 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction
Measured: 3 months
Secondary outcomes (5)
Change in sexual activity leading to optimal penetration
Change in sexual activity leading to optimal penetration measured by SEP- Sexual Encounter Profile questionnaire. The SEP questionnaire consists of 5 items addressing the sexual events and subject experiences when attempting intercourse. Efficacy of RF treatment evaluated using the change in percentage of "yes" responses to Sexual Encounter Profile (SEP) Questions 2 and 3
Measured: 3 months
Evaluate efficacy of the RF treatment for erectile function
Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'.
Measured: 3 months
Evaluate efficacy of the RF treatment for erectile function
Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'.
Measured: 6 months
Evaluate efficacy of the RF treatment for erectile function
Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'.
Measured: 12 months
Evaluate efficacy of the RF treatment for hardness of erection
To assess the effectiveness of RF treatment for erectile dysfunction with the Erectile Hardness Score (EHS) questionnaire The Erection Hardness Score is a self-reported tool that measures the hardness of an erection.
It involves a scale report from 0 to 4, 4 being the best quality of erection.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start23 Jun 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2025 (estimated)
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
- Model description
- Prospective, open-label clinical study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Valenzuela, MD, Principal investigatorLanna Cheuck, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299332
- Sponsor's protocol ID
- DO611503A
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 7 Mar 2024
- Results posted
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06299332
- Acronym / sponsor ID
- DO611503A
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 7 Mar 2024 (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.
The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label clinical study.
| Arm | Type | Receives |
|---|---|---|
| Device Treatment | Experimental | Device: Device treatmentEligible subjects will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult male between ≥40 and ≤80 years of age
- Subjects with a history of self-reported erectile dysfunction lasting for over 6 months and not more than 5 years.
- The subject is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- The subject has been in a stable heterosexual relationship for over 3 months prior to enrollment.
- A minimum of 4 sexual attempts during the last two weeks prior to enrollment.
Key exclusion criteria (21 listed)
- Evidence of co-existing Neurological disease or other systemic disease conditions such as Alzheimer or Parkinson disease which affects erectile function (at the discretion of the investigator)
- History of radical prostatectomy or extensive pelvic surgery ever
- Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
- Anatomical malformation of the penis, including Peyronie's disease.
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
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 |
|---|---|---|
| Device treatment20 heterosexual males clinically diagnosed with Erectile Dysfunction will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit | Device | Device Treatment |
Primary outcome
Change in ED symptoms, following the RF treatment
Time frame: 3 months
Change in ED symptoms, following the RF treatment measured by THE INTERNATIONAL INDEX OF ERECTILE FUNCTION - ERECTILE FUNCTION (IIEF-EF) questionnaire score. The IIEF-5 score is the sum of the ordinal responses to the 5 items.(1 to 5 ) 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction
5 secondary outcomes
Change in sexual activity leading to optimal penetration
Time frame: 3 months
Evaluate efficacy of the RF treatment for erectile function
Time frame: 3 months
Evaluate efficacy of the RF treatment for erectile function
Time frame: 6 months
Evaluate efficacy of the RF treatment for erectile function
Time frame: 12 months
Evaluate efficacy of the RF treatment for hardness of erection
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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.
Robert Valenzuela, MD principal investigator
Lanna Cheuck, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device treatment in people with Erectile Dysfunction, run by InMode MD Ltd. at 2 sites 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 14 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MEITAL MATALON (9492396522, meital.matalon@inmodemd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ED symptoms, following the RF treatment (time frame: 3 months). 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 7 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.