Clinical trial NCT06299332: Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction
Official title: Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open-label clinical study.
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

1. Adult male between ≥40 and ≤80 years of age
2. Subjects with a history of self-reported erectile dysfunction lasting for over 6 months and not more than 5 years.
3. The subject is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
4. The subject has been in a stable heterosexual relationship for over 3 months prior to enrollment.
5. A minimum of 4 sexual attempts during the last two weeks prior to enrollment.
6. Abstinence from taking PDE5 for two weeks (washout) after enrolment and 2 weeks before each follow up visit/call.
7. IIEF-EF score between 11 and 25.
8. Testosterone level 300-1000 mg/dL within 1 month prior to the enrollment/baseline.
9. A1C level ≤ 8.5% within 1 month prior to enrollemnt/baseline.
10. Subject has at EHS score ≥ 1 (natural tumescence during sexual stimulation).
11. 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
12. If the FirmTech Ring is provided, the participants must be willing to use the ring according to the instructions.
13. The subjects should be willing to comply with the study procedure and schedule, including follow up visits.
14. 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.

Exclusion Criteria:

1. 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)
2. History of radical prostatectomy or extensive pelvic surgery ever
3. Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
4. Anatomical malformation of the penis, including Peyronie's disease.
5. Testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
6. Diabetes type I
7. Diabetes Type II with A1C level \> 8.5% within 1 month prior to enrollment.
8. Unwillingness to abstain from systemic medications known to cause ED for the study duration.
9. Internal defibrillator, pacemaker or any other implanted electrical device anywhere in the body
10. Permanent metal implant in the treatment area
11. Any surgery in the treatment area in the last 3 months
12. Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles in the facial area
13. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
14. 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.
15. Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction
16. Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes and rash.
17. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
18. Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
19. Use of Isotretinoin (Accutane®) within 30 days prior to treatment.
20. Participation in another study within 30 days prior to screening.

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Primary outcomes:
measure: Change in ED symptoms, following the RF treatment
timeFrame: 3 months
Secondary outcomes:
measure: Change in sexual activity leading to optimal penetration
timeFrame: 3 months
measure: Evaluate efficacy of the RF treatment for erectile function
timeFrame: 3 months
measure: Evaluate efficacy of the RF treatment for erectile function
timeFrame: 6 months
measure: Evaluate efficacy of the RF treatment for erectile function
timeFrame: 12 months
measure: Evaluate efficacy of the RF treatment for hardness of erection
timeFrame: 3 months
Other outcomes:
measure: Measuring pain level during the procedure
timeFrame: During the procedure
Locations:
city: New York
country: United States
facility: LC Medical 140 W 58th St, Suite A New York, NY 10019
state: New York
city: New York
country: United States
facility: Washington Heights Urology
state: New York
Study officials:
name: Robert Valenzuela, MD
role: PRINCIPAL_INVESTIGATOR
name: Lanna Cheuck, MD
role: PRINCIPAL_INVESTIGATOR
References: