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ENROLLING BY INVITATION
NCT04200937

IT Matters: The Erectile Restoration Registry

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

450

Start Date

2021-08-05

Completion Date

2031-12

Last Updated

2026-03-12

Healthy Volunteers

Yes

Interventions

DEVICE

Tactra Malleable

The Tactra™ Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are suitable candidates for implantation procedure.

DEVICE

Spectra™ Concealable Penile Prothesis

The Spectra Penile Prothesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

DEVICE

AMS Ambicor™ Inflatable Penile Prosthesis

The AMS Ambicor inflatable penile prothesis intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in adult men who are determined to be suitable candidates for implantation surgery.

DEVICE

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

The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

DEVICE

AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump

The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

Locations (25)

USC Medical Center

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Tower Urology-Research Facility

Los Angeles, California, United States

University of Miami Hospital

Miami, Florida, United States

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, United States

University of Chicago

Chicago, Illinois, United States

SIU School of Medicine

Springfield, Illinois, United States

Indiana University Medical Center

Indianapolis, Indiana, United States

Willis-Knighton Medical Center

Bossier City, Louisiana, United States

Washington University in St. Louis

St Louis, Missouri, United States

Duke University Medical Center

Raleigh, North Carolina, United States

W.G. Hefner VA Medical Center

Salisbury, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Washington Medical Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Peking University First Hospital

Beijing, China

Shanghai General Hospital

Shanghai, China

Shanghai Jiaotong University School of Medicine Renji Hospital

Shanghai, China

Johns Hopkins Aramco Healthcare

Dhahran, Saudi Arabia