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Procedure

Device Treatment for Erectile Dysfunction

N/A

Recruiting

Led By Robert Valenzuela, MD

Research Sponsored by InMode MD Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial aims to investigate whether Radiofrequency (RF) therapy is safe and effective for treating erectile dysfunction (ED) symptoms in patients.

Who is the study for?

This trial is for men experiencing erectile dysfunction (ED). Specific eligibility criteria are not provided, but typically participants would need to be adults with a clinical diagnosis of ED.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a device that uses Bi-Polar Radiofrequency (RF) therapy on patients with erectile dysfunction. It's a prospective pilot study, which means it's preliminary research to gather initial data.See study design

What are the potential side effects?

While specific side effects are not listed, RF treatments may potentially cause skin irritation, discomfort or pain at the treatment site, and temporary changes in sensation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in ED symptoms, following the RF treatment

Secondary outcome measures

Change in sexual activity leading to optimal penetration

Evaluate efficacy of the RF treatment for erectile function

Evaluate efficacy of the RF treatment for hardness of erection

Other outcome measures

Measuring pain level during the procedure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device TreatmentExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor

23 Previous Clinical Trials

1,345 Total Patients Enrolled

Robert Valenzuela, MDPrincipal Investigator

Lanna Cheuck, MDPrincipal Investigator

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for potential participants in this study, such as excluding individuals over the age of 80?

"To be eligible for enrollment in this research study, candidates must fall between the age bracket of 40 to 80 years old."

Answered by AI

Am I eligible to be a part of this research trial?

"Applicants must be aged between 40 and 80 years old, presenting with erectile dysfunction to qualify for enrollment in this study. A total of 20 individuals will be recruited into the clinical trial."

Answered by AI

Is the recruitment for this study still ongoing at present?

"Indeed, the details on clinicaltrials.gov show that this trial is actively seeking candidates. The initial posting date was 6/23/2023, and the most recent update occurred on 2/29/2024. The investigation aims to recruit 20 participants from two distinct sites."

Answered by AI

What is the total number of participants enrolled in this clinical investigation?

"Affirmative. Information accessible on clinicaltrials.gov confirms the ongoing recruitment of participants for this trial. Originally shared on June 23, 2023, and last updated on February 29, 2024, the study aims to enroll a total of 20 patients across two designated locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299332.

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