Prometra Post-Approval Study

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854229
• Other study ID #: PAS-01
• Status: Completed
• Phase: N/A
• Start date: June 20, 2013
• Est. completion date: March 15, 2023

Study information

• Verified date: October 2023
• Source: Flowonix Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Cancer Pain
• Chronic Pain
• Intractable Pain
• Pain, Intractable

Intervention

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.

Locations

Country	Name	City	State
United States	Triumph Medical	Asheville	North Carolina
United States	Integrated Pain Solutions	Columbus	Ohio
United States	Neuroscience and Pain Institute	Covington	Louisiana
United States	Interventional Pain Management	Daytona Beach	Florida
United States	Neurospine Institute	Eugene	Oregon
United States	Global Scientific Innovations	Evansville	Indiana
United States	Summit Pain Management	Fort Wayne	Indiana
United States	Summit Research Institute	Fort Wayne	Indiana
United States	Jackson Anesthesia Pain Center	Jackson	Mississippi
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Perlman Clinic	La Jolla	California
United States	Palm Beach Pain Management	Lake Worth	Florida
United States	Bluegrass Pain Consultants	Louisville	Kentucky
United States	Kentuckiana Pain Specialists	Louisville	Kentucky
United States	Pain Care of Oregon	Medford	Oregon
United States	Integrated Pain and Neuroscience	New Orleans	Louisiana
United States	Interventional Pain Management Specialists	Overland Park	Kansas
United States	Nexus Pain Care	Provo	Utah
United States	Evolve Restorative Center	Santa Barbara	California
United States	Pacific Pain Physicians	Santa Barbara	California
United States	Summit Pain Alliance	Santa Rosa	California
United States	Pain Institute of Tampa	Tampa	Florida
United States	BioHealth Pain Management	Torrance	California
United States	Fox Chase Pain Management Associates	Trevose	Pennsylvania
United States	Space City Pain Specialists	Webster	Texas
United States	Pain Management Institute	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Flowonix Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device-related adverse events	Tabulation of device-related adverse events	Five years
Other	Device-related serious adverse events	Tabulation of device-related serious adverse events	Five years
Other	Rate of granuloma formation by race and ethnicity	The effect of race and ethnicity on granuloma formation	Five years
Other	Granuloma formation by drug type	The effect of alternative drugs on granuloma formation	Five years
Primary	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	Pump failure	Tabulation of pump failures, including time to occurrence and type	Five years
Secondary	Pump battery life	Tabulation of occurences of premature pump battery depletions	Five years

External Links

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