Last updated on April 2018

Prometra Post-Approval Study

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT01854229

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Victoria Sumner

Pacific Pain Medicine Consultants
Oceanside, CA United States

Victoria Sumner

San Diego Comprehensive Pain
San Diego, CA United States

Victoria Sumner

Soma Orthopedics Medical Group
San Francisco, CA United States

R. Michael Hullander, MD

Pacific Pain Physicians
Santa Barbara, CA United States

Jason Pope, MD

Summit Pain Alliance
Santa Rosa, CA United States

Rostam Khoshsar, MD

PIH Health Pain Management
Whittier, CA United States

Victoria Sumner

Comprehensive Pain & Headache Treatment Center
Derby, CT United States

Vinod Malik, MD

PRC Associates
Daytona Beach, FL United States

Orlando G Florete, Jr, MD

Florida Institute of Medical Research
Jacksonville, FL United States

Anthony Rogers, MD

Palm Beach Pain Management
Lake Worth, FL United States

John Barsa, MD

Pain Institute of Tampa
Tampa, FL United States

Michael Cozzi, MD

Summit Pain Management
Fort Wayne, IN United States

Daniel Roth, DO

Summit Research Institute
Fort Wayne, IN United States

Daniel Kloster, MD

Interventional Pain Management Specialists
Overland Park, KS United States

Christopher Nelson, MD

Bluegrass Pain Consultants
Louisville, KY United States

Ajith Nair, MD

Kentuckiana Pain Specialists
Louisville, KY United States

Chad M Domangue, MD

Neuroscience and Pain Institute
Covington, LA United States

Eric Royster, MD

Integrated Pain and Neuroscience
New Orleans, LA United States

Carroll M McLeod, MD

Jackson Anesthesia Pain Center
Jackson, MS United States

Victoria Sumner

Center for Interventional Pain Management
St Louis, MO United States

Kenneth Rogers, DO

Advanced Pain Consultants
Voorhees, NJ United States

Javid Baksh, DO

Triumph Medical
Asheville, NC United States

Gladstone McDowell, MD

Integrated Pain Solutions
Columbus, OH United States

A. Harris Basali, MD

Pain Management Institute
Wooster, OH United States

Gregory Phillips, MD

Neurospine Institute
Eugene, OR United States

Joseph Savino, MD

Pain Care of Oregon
Medford, OR United States

Steven Rosen, MD

Fox Chase Pain Management Associates
Trevose, PA United States

Deborah Fisher, MD

Deborah Fisher, MD, PA
Sherman, TX United States

Eduardo A Garcia, MD

Space City Pain Specialist
Webster, TX United States

Richard Rosenthal, MD

Nexus Pain Care
Provo, UT United States