450
Participants
Start Date
August 5, 2021
Primary Completion Date
January 31, 2031
Study Completion Date
December 31, 2031
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.
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.
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.
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).
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).
Thomas Jefferson University Hospital, Philadelphia
Wake Forest University, Winston-Salem
Duke University Medical Center, Raleigh
W.G. Hefner VA Medical Center, Salisbury
University of Miami Hospital, Miami
USF Health South Tampa Center for Advanced Healthcare, Tampa
Johns Hopkins Aramco Healthcare, Dhahran
Ohio State University Wexner Medical Center, Columbus
Cleveland Clinic, Cleveland
Indiana University Medical Center, Indianapolis
Medical College of Wisconsin, Milwaukee
University of Chicago, Chicago
SIU School of Medicine, Springfield
Washington University in St. Louis, St Louis
Willis-Knighton Medical Center, Bossier City
Baylor College of Medicine, Houston
Houston Methodist Hospital, Houston
University of Utah, Salt Lake City
USC Medical Center, Los Angeles
Ronald Reagan UCLA Medical Center, Los Angeles
University of Washington Medical Center, Seattle
Tower Urology-Research Facility, Los Angeles
Peking University First Hospital, Beijing
Shanghai General Hospital, Shanghai
Shanghai Jiaotong University School of Medicine Renji Hospital, Shanghai
Lead Sponsor
Boston Scientific Corporation
INDUSTRY