Prometra Post-Approval Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain, Cancer Pain, Intractable Pain, Back Pain

Intervention / Treatment
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* Device: Prometra Programmable Intrathecal Infusion Pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient meets at least one of the following: is suffering from malignant pain (i.e., cancer pain) has chronic, non-malignant pain subject was enrolled in PUMP I or PUMP II study and chooses to participate in this Post-Approval study Patient with an existing implantable pump for pain therapy that requires replacement Patient is at least 22 years of age. Investigator considers the patient to be able and willing to fulfill all study requirements. Patient has provided written informed consent to participate in the study. Exclusion Criteria: Patient meets any of the contraindications for use of the Prometra System Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prospective pump candidates<br>New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump | Device: Prometra Programmable Intrathecal Infusion Pump<br>* 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.<br>* Other names: Flowonix pump;|
| Active Comparator: Previous IDE study subjects continuing with the therapy<br>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. | Device: Prometra Programmable Intrathecal Infusion Pump<br>* 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.<br>* Other names: Flowonix pump;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of 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. | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pump failure | Tabulation of pump failures, including time to occurrence and type | Five years | 
| Pump battery life | Tabulation of occurences of premature pump battery depletions | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morphine, Implantable Infusion Pumps, Intrathecal Pump