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A significant local issue has to led to the suspension of recruitment, this study will be terminated in the coming months
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14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Subjects | All subjects recruited and treated with the Axium neurostimulator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation with the commercially available Axium neurostimulator | Device |
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| 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) to 10 (maximum). | Baseline, 3, 6 and12-Months |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic Neuropathic Pain of the Foot and/or Lower Leg
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Nikolaas | Sint-Niklaas | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Subjects | All subjects enrolled into the study with intent to treat with the Axium Neurostimulator for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Received Trial System |
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| Receiving Permanent System |
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| COMPLETED |
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| NOT COMPLETED |
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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 |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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) to 10 (maximum). | Differences in participants over time is due to early withdrawals and missing data | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6 and12-Months |
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All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
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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 | 1 | 10 | 1 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Central disc hernia at L5-S1 and discreet bulging at L4-L5 | Musculoskeletal and connective tissue disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache and nausea | Injury, poisoning and procedural complications | These Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roni Diaz | St. Jude Medical | +1 972 309 8601 | rdiaz@sjm.com |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 6-Months |
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| 12-Months |
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