Clinical Evaluation of the Infinity DBS System



Status:Active, not recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:2/22/2019
Start Date:January 31, 2017
End Date:March 2020

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Trial Summary
Trial Overview
Inclusion Criteria

Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System

The purpose of this post-market study is to characterize the clinical performance of the
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads,
extensions, iPad clinician programmer, iPod patient controller and related system components.


Inclusion Criteria:

- Subject is able to provide informed consent;

- Subject is diagnosed with Parkinson's disease (PD) and has been recommended to receive
an Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN),
or has received an implant of an Infinity system with bilateral lead implants in the
STN;

- Subject must be available for follow-up visits.

Exclusion Criteria:

- Subject is not a surgical candidate;

- In the investigator's opinion, the subject is unable to tolerate multiple programming
sessions within a single setting;

- Subject is unable to comply with the follow-up schedule.
We found this trial at
21
sites
University of Colorado Hospital
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Phone: 720-848-2080
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-0060
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-7772
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Albany Medical College at Albany Medical Center
Albany, New York 12208
Phone: 518-262-5088
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Albany, NY
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Johns Hopkins University Hospital
Baltimore, Maryland 21287
Phone: 410-502-0133
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Baltimore, MD
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St Luke'S Hospital And Health Network
801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
Phone: 484-526-5210
St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
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Bethlehem, PA
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-2423
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Rush University Medical Center
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-563-2900
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-444-2568
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Neurology Consultants of Dallas, PA
Dallas, Texas 75231
Phone: 214-750-9977
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Dallas, TX
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Shands at the University of Florida
Gainesville, Florida 32610
Phone: 352-273-5550
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Gainesville, FL
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UZ Gent
185 De Pintelaan
Gent, 9000
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Gent,
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Chi St. Luke'S Health Baylor College Of Medicine Medical Center
Houston, Texas 77030
Phone: 713-798-8259
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Houston, TX
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Mayo Clinic, Jacksonville
Jacksonville, Florida 32216
Phone: 904-953-2000
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Jacksonville, FL
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University of Miami Hospital
1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Phone: 305-243-6732
University of Miami Hospital The University of Miami changed the face of modern health care...
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Miami, FL
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New York University Langone Medical Center - Tisch Hospital
New York, New York 10016
Phone: 212-263-2607
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New York, NY
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Mount Sinai Hosp
New York, New York 10029
Phone: 212-241-6960
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New York, NY
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Pennsylvania Hospital
800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Phone: 215-823-5800
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Philadelphia, PA
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Thomas Jefferson University Hospital
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-503-2724
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, PA
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Allegheny Singer Research Institute
Pittsburgh, Pennsylvania 15212
Phone: 724-228-1414
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Pittsburgh, PA
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Kaiser Permanente Sacramento Medical Center
Sacramento, California 95825
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Sacramento, CA
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