Inflatable Penile Prosthesis for Erectile Dysfunction

(UNITED Trial)

Not yet recruiting at 5 trial locations

Overseen By Zeynep Tin Konukcu

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Rigicon, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.

Are You a Good Fit for This Trial?

This trial is for men with erectile dysfunction who are considering the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) as a treatment option. Specific eligibility criteria have not been provided, but typically participants must meet certain health standards and agree to follow-up assessments.

Inclusion Criteria

Willing to complete all protocol required for follow-up visits and tests

I have been diagnosed with erectile dysfunction.

I am a man aged 22 or older.

Exclusion Criteria

I have been diagnosed with a fibrotic condition like priapism, Peyronie's disease, or Chordee.

Expected life expectancy < two years

Psychogenic erectile dysfunction

What Are the Treatments Tested in This Trial?

Interventions

• Rigicon Infla10® Inflatable Penile Prosthesis (IPP)

Trial Overview The study is testing the safety and effectiveness of the Rigicon Infla10® IPP over a period of up to three years following implantation in patients with erectile dysfunction.

How Is the Trial Designed?

Group I: Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis Experimental Treatment 1 Intervention

Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.

Who Is Running the Clinical Trial?

Rigicon, Inc.

Lead Sponsor

Trials

1

Recruited

180+