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20-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axium DRG Neurostimulator | All eligible subjects recruited and treated with the Axium Neurostimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axium DRG Neurostimulator | Device | Implantation with Axium DRG Neurostimulator |
|
| 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, 12 and 24-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, 12 and 24-Month Visits |
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Inclusion Criteria:
Exclusion Criteria:
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Patient suffering from chronic post surgical pain
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Medisch Centrum | Amsterdam | Netherlands |
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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 |
| 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, 12 and 24-Month Visits |
|
Adverse events were collected from Informed Consent through study exit (24-Month visit).
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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 |
|---|---|---|---|---|---|
| Increasing pain due to lead failure/malfunction | Product Issues | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken lead | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Duggan | St. Jude Medical | +32(0)27746827 | jduggan@sjm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2013 | Nov 13, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| years |
|
| 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, 12 and 24-Month Visits |
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| 8 |
| 30 |
| Low blood sodium level | Investigations | Non-systematic Assessment |
|
| Lead damaged due to accidental incision | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Malignant tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| IPG migration | Product Issues | Non-systematic Assessment |
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| Lead migration | Product Issues | Non-systematic Assessment |
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| Pain at IPG Pocket | General disorders | Non-systematic Assessment |
|
| Partial loss of stimulation and pain at IPG pocket | Product Issues | Non-systematic Assessment | These Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated. |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bleeding/Hematoma | Vascular disorders | Non-systematic Assessment |
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| Dura Puncture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Foot injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Increased pain in the target area | General disorders | Non-systematic Assessment |
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| Kicking movement during the night | Nervous system disorders | Non-systematic Assessment |
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| Loss of stimulation | Product Issues | Non-systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Spinal Tap | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 12-Month Visit |
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| 24-Month Visit |
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