Open Actively Recruiting

IT Matters: The Erectile Restoration Registry

About

Brief Summary

The primary objective of the It MATTERS registry is to assess erectile function at 6 months, post implantation of an It MATTERS Study Penile Prosthesis, demonstrating an improvement in quality of life from baseline.

Study Type
Observational
Phase
Phase IV

Eligibility

Gender
Male
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Males who are >/= 18 years of age.
  • Males with chronic, organic, erectile dysfunction (impotence) who are determined to be suitable candidates for implantation surgery by their physician.
  • Willing and able to undergo surgical implantation of a study BSC penile prothesis device.
  • Willing and able to complete the informed consent process.
  • Willing and able to comply with the follow-up requirement.

Exclusion Criteria:

  • Men who are deemed by their physician as not suitable for a penile prothesis will be excluded per the contraindications in each study device's Instructions for Use (IFU).

Join this Trial

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Study Stats
Protocol No.
21-001769
Category
Urology
Contact
JASMYN AKANINWOR
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04200937
For detailed technical eligibility, visit ClinicalTrials.gov.