Prometra Post-Approval Study

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Chronic Pain; Cancer Pain; Intractable Pain
• Intervention / Treatment: Device: Prometra Programmable Intrathecal Infusion 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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Perlman Clinic
    • Santa Barbara, California, United States, 93105
      • Pacific Pain Physicians
    • Santa Barbara, California, United States, 95403
      • Evolve Restorative Center
    • Santa Rosa, California, United States, 95401
      • Summit Pain Alliance
    • Torrance, California, United States, 90260
      • BioHealth Pain Management
  • Florida
    • Daytona Beach, Florida, United States, 32174
      • Interventional Pain Management
    • Jacksonville, Florida, United States, 32257
      • Florida Institute of Medical Research
    • Lake Worth, Florida, United States, 33462
      • Palm Beach Pain Management
    • Tampa, Florida, United States, 33603
      • Pain Institute of Tampa
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Global Scientific Innovations
    • Fort Wayne, Indiana, United States, 46802
      • Summit Pain Management
    • Fort Wayne, Indiana, United States, 46825
      • Summit Research Institute
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Interventional Pain Management Specialists
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Bluegrass Pain Consultants
    • Louisville, Kentucky, United States, 40241
      • Kentuckiana Pain Specialists
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Neuroscience and Pain Institute
    • New Orleans, Louisiana, United States, 70115
      • Integrated Pain and Neuroscience
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Jackson Anesthesia Pain Center
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Triumph Medical
  • Ohio
    • Columbus, Ohio, United States, 43219-1531
      • Integrated Pain Solutions
    • Wooster, Ohio, United States, 44691
      • Pain Management Institute
  • Oregon
    • Eugene, Oregon, United States, 97401
      • NeuroSpine Institute
    • Medford, Oregon, United States, 97504
      • Pain Care of Oregon
  • Pennsylvania
    • Trevose, Pennsylvania, United States, 19053
      • Fox Chase Pain Management Associates
  • Texas
    • Webster, Texas, United States, 77598
      • Space City Pain Specialists
  • Utah
    • Provo, Utah, United States, 84604
      • Nexus Pain Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related adverse events	Tabulation of device-related adverse events	Five years
Device-related serious adverse events	Tabulation of device-related serious adverse events	Five years
Rate of granuloma formation by race and ethnicity	The effect of race and ethnicity on granuloma formation	Five years
Granuloma formation by drug type	The effect of alternative drugs on granuloma formation	Five years

Collaborators and Investigators

• Sponsor: Flowonix Medical
• Investigators: Study Director: Cory Brantley, Flowonix Medical

Publications and helpful links

General Publications

• Rauck R, Deer T, Rosen S, Padda G, Barsa J, Dunbar E, Dwarakanath G. Long-term follow-up of a novel implantable programmable infusion pump. Neuromodulation. 2013 Mar-Apr;16(2):163-7. doi: 10.1111/j.1525-1403.2012.00515.x. Epub 2012 Oct 11.

Helpful Links

• American Academy of Pain Medicine
• North American Neuromodulation Society
• American Society of Regional Anesthesia and Pain Medicine
• World Institute of Pain

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2013
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (Estimated): May 15, 2013

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Morphine; Implantable Infusion Pumps; Intrathecal Pump
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Pain, Intractable; Cancer Pain
• Other Study ID Numbers: PAS-01