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10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated subjects | All subjects recruited and treated with the Axium neurostimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation with the commercially available Axium neurostimulator | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain). | Baseline, 3, 6 and 12-Month Visits |
| Percentage of Subjects With at Least 50% Pain Reduction | Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum). | 3, 6 and 12-Month Visits |
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Inclusion Criteria:
Exclusion Criteria:
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Peripheral Neuropathy Patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heinrich Heine Universität Düsseldorf | Düsseldorf | 40225 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Axium DRG Neurostimulator | All subects implanted with intent to treat with the Axium DRG Neurostimulator |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | All subjects enrolled into the study with intent to treat with the Axium Neurostimulator |
| 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 | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain). | Differences in participants over time is due to early withdrawals and missing data | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6 and 12-Month Visits |
|
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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 | All Enrolled Subjects | All subjects enrolled into the study with intent to treat with the Axium Neurostimulator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IPG Pocket Pain due to IPG displacement to ventral | Product Issues |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of Stimulation | Product Issues |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Duggan | St. Jude Medical | +32(0)27746827 | jduggan@sjm.com |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Subjects With at Least 50% Pain Reduction | Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum). | Differences in participants over time is due to early withdrawals and missing data | Posted | Count of Participants | Participants | 3, 6 and 12-Month Visits |
|
|
|
| 0 |
| 33 |
| 8 |
| 33 |
| 5 |
| 33 |
| Loss of Stimulation | Product Issues |
|
| Conus cauda syndrome | Nervous system disorders |
|
| CSF leak | Injury, poisoning and procedural complications |
|
| Infection at IPG site | Infections and infestations |
|
| Leriche's syndrome | Vascular disorders |
|
| Loss of bladder control, sensational numbness, coordination problem right arm | Injury, poisoning and procedural complications |
|
| Nausea and headache | Injury, poisoning and procedural complications | This Adverse Events was monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated. |
|
| Suicide Attempt | Psychiatric disorders |
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| Hematoma | Vascular disorders |
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| Overstimulation | Product Issues |
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| Wound dehiscence | Injury, poisoning and procedural complications |
|
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| 12-Month Visit |
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