Clinical trial NCT01854229: Prometra Post-Approval Study
Official title: A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Cancer Pain
Intractable Pain
Back Pain
Keywords: Morphine
Implantable Infusion Pumps
Intrathecal Pump
Lead sponsor: Flowonix Medical
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 400
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of granuloma formation
timeFrame: Five years
Secondary outcomes:
measure: Pump failure
timeFrame: Five years
measure: Pump battery life
timeFrame: Five years
Other outcomes:
measure: Device-related adverse events
timeFrame: Five years
measure: Device-related serious adverse events
timeFrame: Five years
measure: Rate of granuloma formation by race and ethnicity
timeFrame: Five years
measure: Granuloma formation by drug type
timeFrame: Five years
Locations:
city: La Jolla
country: United States
facility: Perlman Clinic
state: California
city: Santa Barbara
country: United States
facility: Pacific Pain Physicians
state: California
city: Santa Barbara
country: United States
facility: Evolve Restorative Center
state: California
city: Santa Rosa
country: United States
facility: Summit Pain Alliance
state: California
city: Torrance
country: United States
facility: BioHealth Pain Management
state: California
city: Daytona Beach
country: United States
facility: Interventional Pain Management
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Lake Worth
country: United States
facility: Palm Beach Pain Management
state: Florida
city: Tampa
country: United States
facility: Pain Institute of Tampa
state: Florida
city: Evansville
country: United States
facility: Global Scientific Innovations
state: Indiana
city: Fort Wayne
country: United States
facility: Summit Pain Management
state: Indiana
city: Fort Wayne
country: United States
facility: Summit Research Institute
state: Indiana
city: Overland Park
country: United States
facility: Interventional Pain Management Specialists
state: Kansas
city: Louisville
country: United States
facility: Bluegrass Pain Consultants
state: Kentucky
city: Louisville
country: United States
facility: Kentuckiana Pain Specialists
state: Kentucky
city: Covington
country: United States
facility: Neuroscience and Pain Institute
state: Louisiana
city: New Orleans
country: United States
facility: Integrated Pain and Neuroscience
state: Louisiana
city: Jackson
country: United States
facility: Jackson Anesthesia Pain Center
state: Mississippi
city: Asheville
country: United States
facility: Triumph Medical
state: North Carolina
city: Columbus
country: United States
facility: Integrated Pain Solutions
state: Ohio
city: Wooster
country: United States
facility: Pain Management Institute
state: Ohio
city: Eugene
country: United States
facility: Neurospine Institute
state: Oregon
city: Medford
country: United States
facility: Pain Care of Oregon
state: Oregon
city: Trevose
country: United States
facility: Fox Chase Pain Management Associates
state: Pennsylvania
city: Webster
country: United States
facility: Space City Pain Specialists
state: Texas
city: Provo
country: United States
facility: Nexus Pain Care
state: Utah
Study officials:
affiliation: Flowonix Medical
name: Cory Brantley
role: STUDY_DIRECTOR
References:
citation: 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.