Prometra Post-Approval Study

Flowonix Medical400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Chronic Pain Cancer Pain Intractable Pain Back Pain

Interventions

Prometra Programmable Intrathecal Infusion PumpDEVICE

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Patient is at least 22 years of age. 3. Investigator considers the patient to be able and willing to fulfill all study requirements. 4. Patient has provided written informed consent to participate in the study. Exclusion Criteria: 1. Patient meets any of the contraindications for use of the Prometra System 2. Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma. 3. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.

Locations (26)

Perlman Clinic

Outcomes

Primary Outcomes

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.

Time frame: Five years

Secondary Outcomes

Pump failure

Tabulation of pump failures, including time to occurrence and type

Time frame: Five years

Pump battery life

Tabulation of occurences of premature pump battery depletions

Time frame: Five years

Data from ClinicalTrials.gov

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