Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

NCT ID: NCT02208999

Last Updated: 2019-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-12-31

Brief Summary

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Assessing the long-term efficacy, complications, revision rates and final explantation of the device

Detailed Description

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Longitudinal study with a follow-up of 2 years in patients implanted with the Precision neurostimulator.

This study will describe the characterisrics of the patients, of the implantation and will assess the long-term efficacy, complications, revision rates and final explantation of the device

Conditions

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Chronic Refractory Neuropathic Pain Ischemic Peripheral Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurostimulator Precision

Patients implanted or reimplanted with the neurostimulator Precision

Neurostimulator Precision

Intervention Type DEVICE

All patients included must have been implanted with the neurostimulator Precision

Interventions

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Neurostimulator Precision

All patients included must have been implanted with the neurostimulator Precision

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patient receiving spinal implantation of a neurostimulator PRECISION ® ( primary implantation or reimplantation)

Exclusion Criteria

* Refusal of patient
* Patient whose long-term monitoring will not be possible
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Cemka-Eval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Dr Mouton, MD

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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Hospitals implanting the neurostimulator Precision

Multiple Locations, , France

Site Status

Countries

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France

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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913018

Identifier Type: OTHER

Identifier Source: secondary_id

2011045

Identifier Type: -

Identifier Source: org_study_id

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