Prometra Post-Approval Study

Status Completed

Clinical Trial Summary

The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

Clinical Trial Description

This study is proposed under part of the post-Premarket Approval (PMA) requirements. This study is a prospective, non-randomized, open-label, multicenter study. It will be performed at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01854229
Study type	Interventional
Source	Flowonix Medical
Contact
Status	Completed
Phase	N/A
Start date	June 20, 2013
Completion date	March 15, 2023

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