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Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED) - Trial NCT05574868

Access comprehensive clinical trial information for NCT05574868 through Pure Global AI's free database. This phase not specified trial is sponsored by Rigicon, Inc. and is currently Recruiting. The study focuses on Erectile Dysfunction. Target enrollment is 177 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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ClinicalTrials.govNCT05574868
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Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
Evaluation of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction

Study Focus

Erectile Dysfunction

Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis

Interventional

device

Sponsor & Location

Rigicon, Inc.

Ankara,Istanbul,Istanbul, Turkey

Timeline & Enrollment

N/A

Jul 11, 2022

May 21, 2026

177 participants

Primary Outcome

Rigidity at 12 months,Survival at 12 months

Summary

This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10®
 Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study
 follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile
 Prosthesis for up to 3 years after implantation.
 
 This study will take approximately 6 months to enroll all subjects. (14 days, 1 month, 6
 months, 12 months,18 months, 24 months, and 36 months, post-procedure. )
 
 Subjects will be followed per protocol and institutional standard of care for ED and
 comorbidities.

ICD-10 Classifications

Orgasmic dysfunction
Other disorders of penis
Other specified disorders of penis
Sexual dysfunction, not caused by organic disorder or disease
Testicular dysfunction

Data Source

ClinicalTrials.gov

NCT05574868

Device Trial