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

NCT06299332 | Unknown FDA Device

• 1 other identifier: DO611503A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (5)

• Change in sexual activity leading to optimal penetration

  3 months

• Evaluate efficacy of the RF treatment for erectile function

  3 months

• Evaluate efficacy of the RF treatment for erectile function

  6 months

• Evaluate efficacy of the RF treatment for erectile function

  12 months

• Evaluate efficacy of the RF treatment for hardness of erection

  3 months

Other Outcomes (1)

• Measuring pain level during the procedure

  During the procedure

Study Arms (1)

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.

Device: Device treatment

Interventions

Device treatment 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

Device Treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: 20 heterosexual males clinically diagnosed with Erectile Dysfunction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (2)

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

New York, New York, 10019, United States

RECRUITING

Washington Heights Urology

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Robert Valenzuela, MD

  PRINCIPAL INVESTIGATOR

• Lanna Cheuck, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MEITAL MATALON

CONTACT

9492396522; meital.matalon@inmodemd.com

Maria Shusterman

CONTACT

9492396522; maria.shusterman@inmodemd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label clinical study.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: March 7, 2024
• Study Start: June 23, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)