Back Pain, Cancer Pain, Chronic Pain, Intractable Pain
Conditions
Keywords
Morphine, Implantable Infusion Pumps, Intrathecal Pump
Brief 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.
Interventions
DEVICEPrometra 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.
Sponsors
Flowonix Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of granuloma formation | Five years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pump failure | Five years | Tabulation of pump failures, including time to occurrence and type |
| Pump battery life | Five years | Tabulation of occurences of premature pump battery depletions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Granuloma formation by drug type | Five years | The effect of alternative drugs on granuloma formation |
| Rate of granuloma formation by race and ethnicity | Five years | The effect of race and ethnicity on granuloma formation |
| Device-related adverse events | Five years | Tabulation of device-related adverse events |
| Device-related serious adverse events | Five years | Tabulation of device-related serious adverse events |
Countries
United States
Outcome results
None listed