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| ID | Type | Description | Link |
|---|---|---|---|
| 913018 | Other Identifier | CNIL |
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Assessing the long-term efficacy, complications, revision rates and final explantation of the device
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurostimulator Precision | Patients implanted or reimplanted with the neurostimulator Precision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostimulator Precision | Device | All patients included must have been implanted with the neurostimulator Precision |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale | Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:
| From baseline until the end of the study at 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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All implanted patients (primary implementation and reimplantation) with the neurostimulator PRECISION ®, during the inclusion period (1 year).
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Dr Mouton, MD | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospitals implanting the neurostimulator Precision | Multiple Locations | France |
Individual participant data will not be shared; Only aggregated data will be communicated
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No pre-assignment details
Recruitment between December 3, 2015 and October 21, 2015 in 7 French clinical centers
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Implanted or Reimplanted With Precision | All patients included must have been implanted with the neurostimulator Precision.107 patients were included. One of them was excluded because he was less than 18 years old. So 106 patients were analysed: 91 implanted patients (de novo implants) and 15 reimplanted patients (replacement implants) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Implanted Patients | 91 patients de novo implanted with the neurostimulator Precision. |
| BG001 | Reimplanted Patients | 15 patients had a replacement with the neurostimulator Precision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Implanted patients (de novo implants) | Posted | Number | 95% Confidence Interval | percentage of patients | From baseline until the end of the study at 24 months. |
|
From baseline until the end of the study at 24 months
Each investigator reported all adverse events from baseline until the end of the study at 24 months.
The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Population: Implanted and Reimplanted Patients | Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
Study performed in real-life conditions , based on standard of care and some follow-ups were not considered as routine visits.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stéphane Bouée, Medical director | CEMKA | 331.41.87.95.25 | stephane.bouee@cemka.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2013 | Sep 23, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2016 | Sep 23, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Patients' Opinion on the Evolution of Pain | - Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months. | From baseline until the end of the study at 24 months |
| Evolution of the Use of Other Pain Treatments | Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years) | From baseline until the end of the study at 24 months |
| Evolution of Quality of Life (SF-12) - Physical Score | Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical "quality of life. | From baseline until the end of the study at 24 months |
| Patients' Willingness to Restart the Treatment | Patients' willingness to restart the treatment at 12 months and at 24 months. | From baseline until the end of the study at 24 months |
| Percentage of Patients With Anxiety and Depression Disorders | Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months. | From baseline until the end of the study at 24 months |
| Evolution of Quality of Life (SF-12) - Mental Score | Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental "quality of life. | From baseline until the end of the study at 24 months |
| Evolution of the Use of Level 3 Analgesics | Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients | From baseline until the end of the study at 24 months |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Indication | Type of pain for which the neurostimulator was implanted | 4 missing data | Count of Participants | Participants |
|
| Pain location | 1 missing data | Count of Participants | Participants |
|
| Duration of pain before implant | Mean age of pain (months) | 3 missing data | Mean | Standard Deviation | Months |
|
| History of pain surgery | 3 missing data | Count of Participants | Participants |
|
| % of patients with a test phase before final implantation | 1 missing data | Count of Participants | Participants |
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| Percentage reduction in pain during the test phase | 95 patients had a phase test and 4 data was missing. | Mean | Standard Deviation | percentage |
|
| Electrode insertion pathways | 1 missing data | Count of Participants | Participants |
|
|
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| Secondary | Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale | Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:
| Percentage of de novo patients with an improvement of at least 30% for pain at 12 and 24 months after inclusion | Posted | Number | 95% Confidence Interval | % of patients | From baseline until the end of the study at 24 months |
|
|
|
| Secondary | Patients' Opinion on the Evolution of Pain | - Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months. | Percentage of de novo patients for whom pain relief before the implantation was "improved" to "very improved" at 12 and 24 months | Posted | Count of Participants | Participants | From baseline until the end of the study at 24 months |
|
|
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| Secondary | Evolution of the Use of Other Pain Treatments | Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years) | Implanted patients (de novo implants) at 12 months and at 24 months with at least one analgesic treatment | Posted | Count of Participants | Participants | From baseline until the end of the study at 24 months |
|
|
|
| Secondary | Evolution of Quality of Life (SF-12) - Physical Score | Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical "quality of life. | Percentage of de novo patients with an increase of SF-12 at 12 and 24 months | Posted | Count of Participants | Participants | From baseline until the end of the study at 24 months |
|
|
|
| Secondary | Patients' Willingness to Restart the Treatment | Patients' willingness to restart the treatment at 12 months and at 24 months. | Percentage of de novo patients willing to restart treatment at each follow-up (at 1 year and at 2 years) | Posted | Count of Participants | Participants | From baseline until the end of the study at 24 months |
|
|
|
| Secondary | Percentage of Patients With Anxiety and Depression Disorders | Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months. | Percentage of de novo patients with anxiety and depression disorders at 12 and 24 months | Posted | Number | 95% Confidence Interval | percentage of included de novo patients | From baseline until the end of the study at 24 months |
|
|
|
| Secondary | Evolution of Quality of Life (SF-12) - Mental Score | Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental "quality of life. | Percentage of de novo patients with an increase of SF-12 mental score at 12 and 24 months | Posted | Count of Participants | Participants | From baseline until the end of the study at 24 months |
|
|
|
| Primary | 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. | Implanted patients (de novo implants) | Posted | Mean | 95% Confidence Interval | units on a scale | From baseline until the end of the study at 24 months. |
|
|
|
| Secondary | Evolution of the Use of Level 3 Analgesics | Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients | Implanted patients (de novo implants) at 12 months and at 24 months with at least one level 3 analgesic treatment | Posted | Mean | Standard Deviation | MG | From baseline until the end of the study at 24 months |
|
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|
| 2 |
| 106 |
| 36 |
| 106 |
| 5 |
| 106 |
| EG001 | Patients With an Event Related to the Device | Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision and for whom the AE (or SAE) was related to this device | 0 | 106 | 10 | 106 | 1 | 106 |
| electrode displacement / electrode migration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Neurostimulator migration | Injury, poisoning and procedural complications | Systematic Assessment |
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| Electrode fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Extension fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Undesirable stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Loss of efficacy | Injury, poisoning and procedural complications | Systematic Assessment |
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| Difficulty of charging | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Connector problem | Injury, poisoning and procedural complications | Systematic Assessment |
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| Undesirable stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Loss of efficacy | Injury, poisoning and procedural complications | Systematic Assessment |
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| High impedence | Injury, poisoning and procedural complications | Systematic Assessment |
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| Percutaneous + laminectomy |
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| The most severe pain in the last 8 days |
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