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Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02071134
Recruitment Status : Recruiting
First Posted : February 25, 2014
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date February 21, 2014
First Posted Date February 25, 2014
Last Update Posted Date April 9, 2020
Actual Study Start Date February 2014
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2014)
Improvement in patient's quality of life (QoL) during the study as compared with baseline [ Time Frame: up to 3 years ]
Change in quality of life assessments during the study as compared with baseline
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 24, 2014)
  • Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline [ Time Frame: up to 3 years ]
    Change in patient's motor symptoms as determined by UPDRS during the study as compared with baseline
  • Change in medication usage during the study as compared with baseline [ Time Frame: up to 3 years ]
  • Impression of change scores during the study as compared with baseline [ Time Frame: 3 years ]
    Impression of change scores during the study as compared with baseline
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Official Title Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
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.

Additionally, the utilization of Guide XT (GXT) System when used as a planning tool for the programming of patients with the Boston Scientific's Vercise DBS Systems is also evaluated.

Detailed Description

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.

Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Guide XT (GXT) System when used as a planning tool for programming of patients is also evaluated.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with symptoms of Parkinson's disease that are not adequately controlled with medication
Condition Parkinson's Disease
Intervention Device: 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.
Other Names:
  • Vercise DBS System
  • Boston Scientific
Study Groups/Cohorts Parkinson's disease
Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.
Intervention: Device: Deep Brain Stimulation (DBS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 4, 2016)
1000
Original Estimated Enrollment
 (submitted: February 24, 2014)
300
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Key Inclusion Criteria:

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

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Diane Bowers Diane.bowers@bsci.com
Contact: Roshini Jain 469-766-9888 Roshini.Jain@bsci.com
Listed Location Countries United States
Removed Location Countries France
 
Administrative Information
NCT Number NCT02071134
Other Study ID Numbers A4010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor Boston Scientific Corporation
Collaborators Not Provided
Investigators
Study Director: Roshini Jain Boston Scientific Neuromodulation Corporation
PRS Account Boston Scientific Corporation
Verification Date April 2020