Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Cancer Pain

Back Pain

Chronic Pain

Pain

Pain, Intractable

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump

Patients who were part of the previous IDE study, still have an active Prometra Programmable Intrathecal Infusion Pump, and are willing to continue in a study protocol.

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.

Prometra Programmable Intrathecal Infusion Pump

Cory Brantley

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.

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.

Prometra Post-Approval Study

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

Tabulation of device-related adverse events

Tabulation of device-related serious adverse events

The effect of race and ethnicity on granuloma formation

The effect of alternative drugs on granuloma formation

The primary hypothesis is that the 5-year rate of patients with granuloma formation will be noninferior to that in the literature. The literature rate was found to be approximately 3% and the noninferiority margin will be three percentage points.

Tabulation of pump failures, including time to occurrence and type

Tabulation of occurences of premature pump battery depletions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical

Spots Global Cancer Trial Database for implantable infusion pumps