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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
LC Medical 140 W 58th St, Suite A New York, NY 10019
RECRUITING
New York
Washington Heights Urology
RECRUITING
New York
Contact Information
Primary
MEITAL MATALON
meital.matalon@inmodemd.com
9492396522
Backup
Maria Shusterman
maria.shusterman@inmodemd.com
9492396522
Time Frame
Start Date: 2023-06-23
Estimated Completion Date: 2025-05
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: InMode MD Ltd.

This content was sourced from clinicaltrials.gov