IT Matters: The Erectile Restoration Registry

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boston Scientific Corporation
Study ID
NCT04200937
Status
Enrolling By Invitation

Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Aug 5, 2021
Status verified
May 2026
Primary completion
Jan 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: BSC Penile Prothesis Recipients
    Men for whom BSC Penile Prothesis is recommended.

Primary Outcome Measure

Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra [ Time Frame: Baseline to 6 months ]

Locations (21)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
Tower Urology-Research FacilityLos AngelesCalifornia99048-
USC Medical CenterLos AngelesCalifornia90033-
University of Miami HospitalMiamiFlorida33136-
USF Health South Tampa Center for Advanced HealthcareTampaFlorida33606-
University of ChicagoChicagoIllinois60637-
SIU School of MedicineSpringfieldIllinois62702-
Indiana University Medical CenterIndianapolisIndiana46202-
Willis-Knighton Medical CenterBossier CityLouisiana71111-
Washington University in St. LouisSt LouisMissouri63110-
Duke University Medical CenterRaleighNorth Carolina27609-
W.G. Hefner VA Medical CenterSalisburyNorth Carolina28144-
Wake Forest UniversityWinston-SalemNorth Carolina27103-
Cleveland ClinicClevelandOhio44195-
Ohio State University Wexner Medical CenterColumbusOhio43212-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Baylor College of MedicineHoustonTexas77030-
Houston Methodist HospitalHoustonTexas77030-
University of UtahSalt Lake CityUtah84132-
University of Washington Medical CenterSeattleWashington98195-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By research site
Ronald Reagan UCLA Medical Center· Los Angeles, CATower Urology-Research Facility· Los Angeles, CAUSC Medical Center· Los Angeles, CAUniversity of Miami Hospital· Miami, FLUSF Health South Tampa Center for Advanced Healthcare· Tampa, FLUniversity of Chicago· Chicago, IL

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