NCT01854229

Prometra Post-Approval Study

A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Flowonix Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Pain
• Cancer Pain
• Intractable Pain
• Back Pain

Interventions

Type	Name	Description
DEVICE	Prometra Programmable Intrathecal Infusion Pump	There are two enrollment groups (arms). One is for new patients who are going to have a Prometra Pump implanted. The other arm is for patients who were part of the IDE study prior to FDA approval of the pump, and are willing to continue to be followed as part of a study.

Timeline

• Start date: 2013-06-20
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2013-05-15
• Last updated: 2023-10-18

Locations

26 sites across 1 country: United States