NCT04200937

IT Matters: The Erectile Restoration Registry

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-08-05
• Primary completion: 2031-01-01
• Completion: 2031-12-01
• First posted: 2019-12-16
• Last updated: 2026-04-15

Locations

25 sites across 3 countries: United States, China, Saudi Arabia

Regulatory

• FDA-regulated device study