Prometra Post-Approval Study

Flowonix Medical

Status: Completed

Conditions: Cancer Pain; Back Pain; Intractable Pain; Chronic Pain

Treatments: Device: Prometra Programmable Intrathecal Infusion Pump

Study type: Interventional

Funder types: Industry

Identifiers

NCT01854229

PAS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Prospective pump candidates

Active Comparator group

Description:

New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump

Treatment:

Device: Prometra Programmable Intrathecal Infusion Pump

Previous IDE study subjects continuing with the therapy

Active Comparator group

Description:

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.

Treatment:

Device: Prometra Programmable Intrathecal Infusion Pump