IT Matters: The Erectile Restoration Registry

Last updated: April 16, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Enrolling

Phase

N/A

Condition

Infertility

Male Hormonal Deficiencies/abnormalities

Impotence

Treatment

AMS Ambicor

AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump

Spectra™ Concealable Penile Prothesis

Clinical Study ID

NCT04200937
U0670
  • Ages > 18
  • Male
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 18 years of age.

  2. Males who are determined to be suitable candidates and scheduled to undergo surgicalimplantation 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.

Exclusion

Exclusion Criteria:

  1. Males who are deemed by their physician as not suitable candidates for a penileprosthesis.

  2. In the opinion of the investigator, it is not in best interest of the patient or thestudy for the patient to participate.

Study Design

Total Participants: 450
Treatment Group(s): 7
Primary Treatment: AMS Ambicor
Phase:
Study Start date:
August 05, 2021
Estimated Completion Date:
December 31, 2031

Study Description

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.

Connect with a study center

  • Johns Hopkins Aramco Healthcare

    Dhahran, 34465
    Saudi Arabia

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Tower Urology-Research Facility

    Los Angeles, California 99048
    United States

    Site Not Available

  • USC Medical Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Site Not Available

  • USF Health South Tampa Center for Advanced Healthcare

    Tampa, Florida 33606
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • SIU School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Indiana University Medical Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Willis-Knighton Medical Center

    Bossier City, Louisiana 71111
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University in St. Louis

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Duke University Medical Center

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • W.G. Hefner VA Medical Center

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Wake Forest University

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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