Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
450 participants
OBSERVATIONAL
2021-08-05
2031-12-31
Brief Summary
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Detailed Description
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The study will include adult males who undergo penile prothesis implantation with a market approved BSC device to treat erectile dysfunction.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
2. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.
18 Years
MALE
Yes
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mohit Khera, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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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
Countries
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Other Identifiers
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U0670
Identifier Type: -
Identifier Source: org_study_id