RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-06-23

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06299332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

MEITAL MATALON

CONTACT

9492396522

meital.matalon@inmodemd.com

Maria Shusterman

CONTACT

9492396522

maria.shusterman@inmodemd.com

Principal Investigator

Robert Valenzuela, MD

PRINCIPAL_INVESTIGATOR

Lanna Cheuck, MD

PRINCIPAL_INVESTIGATOR

Study Locations (Sites)

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

New York, New York, 10019

United States

Washington Heights Urology

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: InMode MD Ltd.

Robert Valenzuela, MD, PRINCIPAL_INVESTIGATOR
Lanna Cheuck, MD, PRINCIPAL_INVESTIGATOR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-23

Study Completion Date2025-05

Study Record Updates

Study Start Date2023-06-23

Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

Erectile Dysfunction