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IT Matters: The Erectile Restoration Registry (It MATTERS)

Boston Scientific logo

Boston Scientific

Status

Invitation-only

Conditions

Erectile Dysfunction

Treatments

Device: AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump
Device: AMS Ambicor™ Inflatable Penile Prosthesis
Device: Tactra Malleable
Device: AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump
Device: Spectra™ Concealable Penile Prothesis

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

450 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. ≥ 18 years of age.
  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

  1. Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
  2. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.

Trial design

450 participants in 1 patient group

BSC Penile Prothesis Recipients
Description:
Men for whom BSC Penile Prothesis is recommended.
Treatment:
Device: Spectra™ Concealable Penile Prothesis
Device: AMS 700™ Inflatable Penile Prosthesis w/Tenacio™ Pump
Device: Tactra Malleable
Device: AMS Ambicor™ Inflatable Penile Prosthesis
Device: AMS 700™ Inflatable Penile Prosthesis w/Momentary Squeeze (MS) Pump

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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