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NCT05574868

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
Rigicon, Inc.·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Erectile Dysfunction
Drug/Device/Intervention
Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Rigicon, Inc.
Location
Ankara,Istanbul,Istanbul, Turkey
Timeline & enrollment
Phase
N/A
Start date
Jul 11, 2022
End date
May 21, 2026
Enrollment
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 dysfunctionOther disorders of penisOther specified disorders of penisSexual dysfunction, not caused by organic disorder or diseaseTesticular dysfunction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05574868
Type
Device Trial
About this record

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.