Prometra Post-Approval Study

Description

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 Start Date

June 2013

Estimated Completion Date

December 2020

Interventions

  • Device: Prometra Programmable Intrathecal Infusion Pump

Specialties

  • Internal Medicine: Clinical Pharmacology,Hematology/Oncology,Pain Management
  • Pharmacy: Drug/Product Alerts
  • Pain Management: Oncology

MeSH Terms

  • Back Pain
  • Intractable
  • Intrathecal Infusion Pump
  • Pain
  • Prometra pump

Study ID

Flowonix Medical -- PAS-01

Status

Recruiting

Trial ID

NCT01854229

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

400

Sponsor

Flowonix Medical

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.

Gender

Both

Ages

22 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (29)

Study Location Distance Name Phone Email
Comprehensive Pain Headache Treatment Center - Derby, Connecticut 14.6 miles None None None
Fox Chase Pain Management Associates - Trevose, Pennsylvania 117.1 miles Sue Michael RN 267-288-5601 None
Advanced Pain Consultants - Voorhees, New Jersey 131.2 miles Kenneth Rogers DO 856-489-9877 None
Pain Management Institute - Wooster, Ohio 455.7 miles AlexSandra Davis RN 330-263-8478 None
Summit Research Institute - Fort Wayne, Indiana 618.2 miles Thomas Straub PA 260-748-3650 None
Summit Pain Management - Fort Wayne, Indiana 618.2 miles Hillary Osborn Coordinator 260-748-3650 None
Triumph Medical - Asheville, North Carolina 638.1 miles Michelle Jones RN 828-694-4548 None
Bluegrass Pain Consultants - Louisville, Kentucky 686.4 miles Leigh Wood 502-423-1021 None
Kentuckiana Pain Specialists - Louisville, Kentucky 686.4 miles Ajith Nair MD 502-995-4004 None
Florida Institute of Medical Research - Jacksonville, Florida 895.7 miles Theresa Hanburry Coordinator 904-306-9860 None
Center for Interventional Pain Management - St Louis, Missouri 922.3 miles None None None
PRC Associates - Daytona Beach, Florida 939.3 miles Ronette Bragg 386-274-2977 None
Pain Institute of Tampa - Tampa, Florida 1,057.7 miles John Barsa MD 813-875-5913 None
Palm Beach Pain Management - Lake Worth, Florida 1,086.6 miles Margaret Kryvicky 561-968-2995 None
Jackson Anesthesia Pain Center - Jackson, Mississippi 1,120.8 miles Suzanne Griffith 601-709-0607 None
Interventional Pain Management Specialists - Overland Park, Kansas 1,142.0 miles Dontay Ross Coordinator 913-498-7246 None
Neuroscience and Pain Institute - Covington, Louisiana 1,201.6 miles Stephanie Guidry NPC 985-892-8934 None
Integrated Pain and Neuroscience - New Orleans, Louisiana 1,226.2 miles Ryan Roberts MD 504-300-9020 None
Deborah Fisher MD PA - Sherman, Texas 1,382.5 miles Sarah Crouse 903-957-0470 None
Space City Pain Specialist - Webster, Texas 1,470.8 miles Denise Jarbath Coordinator 281-338-4443 None
Nexus Pain Care - Provo, Utah 1,998.8 miles Shiona MacKay 801-356-6100 None
Pacific Pain Medicine Consultants - Oceanside, California 2,464.5 miles None None None
San Diego Comprehensive Pain - San Diego, California 2,470.1 miles None None None
PIH Health Pain Management - Whittier, California 2,480.5 miles Rosie Drulias RN 562-698-0811 None
Neurospine Institute - Eugene, Oregon 2,507.2 miles Shawn Potts 541-686-3791 None
Pain Care of Oregon - Medford, Oregon 2,525.7 miles Suzanne Sefert 541-608-1990 None
Pacific Pain Physicians - Santa Barbara, California 2,555.6 miles Erika Placencia 805-563-0363 None
Soma Orthopedics Medical Group - San Francisco, California 2,604.5 miles None None None
Summit Pain Alliance - Santa Rosa, California 2,604.9 miles Kathryn Howland 707-623-9803 None

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