This study is accepting new patients by invitation only

IT Matters: The Erectile Restoration Registry

a study on Erectile Dysfunction

Summary

Eligibility
for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jesse Mills (ucla)

Description

Summary

The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses

Details

IT MATTERS is a prospective, multicenter, observational registry that is part of planned, active post market clinical follow-up (PMCF) activity associated with each device.

The study will include adult males who undergo penile prothesis implantation with a market approved BSC device to treat erectile dysfunction.

Keywords

Erectile Dysfunction, Tactra Malleable, Spectra™ Concealable Penile Prothesis, AMS Ambicor™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump, AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump, BSC Penile Prothesis Recipients

Eligibility

You can join if…

Open to males ages 18 years and up

  1. ≥ 18 years of age.
  2. Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician.
  3. Willing and able to complete the informed consent process.
  4. Willing and able to comply with the follow-up requirements.

You CAN'T join if...

  1. Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
  2. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.

Locations

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • Tower Urology-Research Facility
    Los Angeles California 99048 United States
  • USC Medical Center
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Jesse Mills (ucla)
    HS Clinical Professor, Urology, Medicine. Authored (or co-authored) 56 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT04200937
Study Type
Observational
Participants
Expecting 450 study participants
Last Updated