Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction

NCT ID: NCT06299332

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-23
• Study Completion Date: 2025-05-31

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).

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Treatment

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.

Group Type: EXPERIMENTAL

Device treatment

Intervention Type: DEVICE

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

Interventions

Device treatment

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

Intervention Type: DEVICE

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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• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

InMode MD Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Valenzuela, MD

Role: PRINCIPAL_INVESTIGATOR

Lanna Cheuck, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

LC Medical 140 W 58th St, Suite A New York, NY 10019

New York, New York, United States

Site Status: RECRUITING

Washington Heights Urology

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

MEITAL MATALON

Role: CONTACT

meital.matalon@inmodemd.com

9492396522

Maria Shusterman

Role: CONTACT

maria.shusterman@inmodemd.com

9492396522

Facility Contacts

Lanna Cheuck

Role: primary

929-492-2052

Robert Valenzuela

Role: primary

212-781-9696

Other Identifiers

DO611503A

Identifier Type: -

Identifier Source: org_study_id