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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02071134




Registration number
NCT02071134
Ethics application status
Date submitted
21/02/2014
Date registered
25/02/2014
Date last updated
10/10/2024

Titles & IDs
Public title
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Scientific title
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Secondary ID [1] 0 0
A4069
Secondary ID [2] 0 0
A4010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Deep Brain Stimulation (DBS)

Parkinson's disease - Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.


Treatment: Devices: Deep Brain Stimulation (DBS)
Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in patient's quality of life (QoL) during the study as compared with baseline
Timepoint [1] 0 0
up to 3 years

Eligibility
Key inclusion criteria
Key

* Meets criteria established in locally applicable Vercise System Direction for Use
* At least 18 years old

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Meets any contraindication in the Vercise System locally applicable Directions for Use

Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2038
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
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United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
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United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
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United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autonoma de Buenos Aires
Country [17] 0 0
Austria
State/province [17] 0 0
Innsbruck
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Belgium
State/province [20] 0 0
Roeselare
Country [21] 0 0
Canada
State/province [21] 0 0
Halifax
Country [22] 0 0
Canada
State/province [22] 0 0
Québec
Country [23] 0 0
France
State/province [23] 0 0
Créteil
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France
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Lyon
Country [25] 0 0
France
State/province [25] 0 0
Marseille
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France
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Paris
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France
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Rennes
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Germany
State/province [28] 0 0
Berlin
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Germany
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Düsseldorf
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
State/province [32] 0 0
Hamm
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Germany
State/province [33] 0 0
Kiel
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Germany
State/province [34] 0 0
Köln
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Germany
State/province [35] 0 0
Mainz
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Germany
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Marburg
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Germany
State/province [37] 0 0
Oldenburg
Country [38] 0 0
Germany
State/province [38] 0 0
Würzburg
Country [39] 0 0
Hungary
State/province [39] 0 0
Pécs
Country [40] 0 0
Israel
State/province [40] 0 0
Jerusalem
Country [41] 0 0
Israel
State/province [41] 0 0
Tel Aviv
Country [42] 0 0
Israel
State/province [42] 0 0
Tel HaShomer
Country [43] 0 0
Italy
State/province [43] 0 0
Arcugnano
Country [44] 0 0
Italy
State/province [44] 0 0
Ferrara
Country [45] 0 0
Italy
State/province [45] 0 0
Mestre
Country [46] 0 0
Italy
State/province [46] 0 0
Milan
Country [47] 0 0
Italy
State/province [47] 0 0
Pavia
Country [48] 0 0
Italy
State/province [48] 0 0
Rome
Country [49] 0 0
Italy
State/province [49] 0 0
Udine
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Seoul
Country [51] 0 0
Poland
State/province [51] 0 0
Bydgoszcz
Country [52] 0 0
Poland
State/province [52] 0 0
Gdansk
Country [53] 0 0
Poland
State/province [53] 0 0
Warsaw
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
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Spain
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Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Murcia
Country [57] 0 0
Spain
State/province [57] 0 0
Oviedo
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Bristol
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Glasgow
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Liverpool
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Newcastle
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.

The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.

Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.
Trial website
https://clinicaltrials.gov/study/NCT02071134
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Natalie Bloom Lyons
Address 0 0
Boston Scientific Neuromodulation Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Heleen Scholtes
Address 0 0
Country 0 0
Phone 0 0
855-213-9890
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02071134