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IT Matters: The Erectile Restoration Registry

NCT04200937 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2026-05-12

No results posted yet for this study

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

Conditions

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).

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Mohit Khera, MD · Baylor College of Medicine

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2031-01-31
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States
  • China
  • Saudi Arabia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200937 on ClinicalTrials.gov