IT Matters: The Erectile Restoration Registry

Last updated: February 10, 2026
Sponsor: Boston Scientific Corporation
Overall Status: Active - Enrolling

Phase

N/A

Condition

Infertility

Impotence

Male Hormonal Deficiencies/abnormalities

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

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • Peking University First Hospital

    Beijing 1816670, 100034
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai, 200080
    China

    Site Not Available

  • Shanghai Jiaotong University School of Medicine Renji Hospital

    Shanghai, 200127
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai 1796236, 200080
    China

    Site Not Available

  • Shanghai Jiaotong University School of Medicine Renji Hospital

    Shanghai 1796236, 200127
    China

    Site Not Available

  • Johns Hopkins Aramco Healthcare

    Dhahran, 34465
    Saudi Arabia

    Site Not Available

  • Johns Hopkins Aramco Healthcare

    Dhahran 107797, 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

  • Ronald Reagan UCLA Medical Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Tower Urology-Research Facility

    Los Angeles 5368361, California 5332921 99048
    United States

    Site Not Available

  • USC Medical Center

    Los Angeles 5368361, California 5332921 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 Miami Hospital

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • USF Health South Tampa Center for Advanced Healthcare

    Tampa 4174757, Florida 4155751 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

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • SIU School of Medicine

    Springfield 4250542, Illinois 4896861 62702
    United States

    Site Not Available

  • Indiana University Medical Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University Medical Center

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • Willis-Knighton Medical Center

    Bossier City, Louisiana 71111
    United States

    Site Not Available

  • Willis-Knighton Medical Center

    Bossier City 4317639, Louisiana 4331987 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

  • Washington University in St. Louis

    St Louis 4407066, Missouri 4398678 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

  • Duke University Medical Center

    Raleigh 4487042, North Carolina 4482348 27609
    United States

    Site Not Available

  • W.G. Hefner VA Medical Center

    Salisbury 4489985, North Carolina 4482348 28144
    United States

    Site Not Available

  • Wake Forest University

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43212
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus 4509177, Ohio 5165418 43212
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 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

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84132
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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