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
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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).
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Study Stats
Protocol No.
21-001769
Category
Urology
Principal Investigator
Contact
Location
- UCLA Santa Monica