Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

NCT02208999 | Completed Results DMC

• 2 other identifiers: 2011045913018
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Refractory Neuropathic Pain; Ischemic Peripheral Pain

Keywords

medullary neurostimulation; pain; Precision; rechargeable; implantable

Outcome Measures

Primary Outcomes (2)

• Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.

  Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.

  From baseline until the end of the study at 24 months.

• Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.

  The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.

  From baseline until the end of the study at 24 months.

Secondary Outcomes (8)

• Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale

  From baseline until the end of the study at 24 months

• Patients' Opinion on the Evolution of Pain

  From baseline until the end of the study at 24 months

• Evolution of the Use of Other Pain Treatments

  From baseline until the end of the study at 24 months

• Evolution of Quality of Life (SF-12) - Physical Score

  From baseline until the end of the study at 24 months

• Patients' Willingness to Restart the Treatment

  From baseline until the end of the study at 24 months

Study Arms (1)

Neurostimulator Precision

Patients implanted or reimplanted with the neurostimulator Precision

Device: Neurostimulator Precision

Interventions

Neurostimulator Precision DEVICE

All patients included must have been implanted with the neurostimulator Precision

Neurostimulator Precision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All implanted patients (primary implementation and reimplantation) with the neurostimulator PRECISION ®, during the inclusion period (1 year).

You may qualify if:

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

You may not qualify if:

• Refusal of patient
• Patient whose long-term monitoring will not be possible

Sponsors & Collaborators

• Cemka-Eval: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Hospitals implanting the neurostimulator Precision

Multiple Locations, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study performed in real-life conditions , based on standard of care and some follow-ups were not considered as routine visits.

Results Point of Contact

• Title: Stéphane Bouée, Medical director
• Organization: CEMKA

stephane.bouee@cemka.fr

331.41.87.95.25

Study Officials

• Elisabeth Dr Mouton, MD

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 6, 2019
• Results First Posted: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)