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| Name | Class |
|---|---|
| Vertos Medical, Inc. | INDUSTRY |
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This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decompression with mild® Device Kit | Active Comparator | Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s). |
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| Sham lumbar decompression | Sham Comparator | Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Lumbar Decompression | Device | Fluoroscopic percutaneous lumbar decompression of the central spinal canal |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) <=4 | Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below. | Week 6 to 12 prior to cross-over |
| Visual Analog Scale (VAS) <=4 | VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below. | Week 6 to 12 & Year One After Sham to mild x-over |
| Visual Analog Scale (VAS) Mean Improvement | VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups. | Baseline and Year 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Grigsby, MD | Napa Pain Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Napa Pain Institute | Napa | California | 94558 | United States |
Randomization occurred in blocks of four. After Week 6 post-treatment and prior to Week 12, Sham arm participants were allowed to have the mild decompression procedure with bone and tissue removal if they chose to have it.
Recruitment occurred 4-19-10 to 7-28-10
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| ID | Title | Description |
|---|---|---|
| FG000 | Percutaneous Decompression Procedure Only | Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit |
| FG001 | Sham Then Percutaneous Decompression With Mild |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Prior to Sham Cross-over, 6-12 Weeks |
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| Sham lumbar decompression | Device | Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal. |
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Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
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| After Sham Cross-over to Mild, One Year |
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ITT analysis includes all patients at weeks 6 to 12 post-treatment. Year 1 cohort analysis includes the 18 mild patients who reported outcomes at Year 1 and the 13 sham patients who reported outcomes at Year 1 after cross-over to mild.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Procedure | Group 1: mild percutaneous decompression with removal of bone and tissue |
| BG001 | Sham Procedure | Group 2: sham decompression with trocar placement and no bone or tissue removal |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||||||
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| Primary | Visual Analog Scale (VAS) <=4 | Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below. | All 40 participants (20 in each arm) reported VAS at six weeks to twelve weeks post-treatment. All measurements for the sham group occurred prior to cross-over to the mild procedure. Patients with scores of 4 or less in each study group are reported below. This is Intent to Treat (ITT)analysis. | Posted | Number | participants | Week 6 to 12 prior to cross-over |
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| Primary | Visual Analog Scale (VAS) <=4 | VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below. | Patients who reported Year 1 outcomes are reported at Week 6-12 and at Year 1. All findings reported below for the Sham group are after cross-over to mild. | Posted | Number | participants | Week 6 to 12 & Year One After Sham to mild x-over |
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| Primary | Visual Analog Scale (VAS) Mean Improvement | VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups. | All patients who reported Year-1 outcomes (Year-1 Cohort) were analyzed. The Sham Year-1 cohort represent those original Sham patients who crossed over from Sham to the mild procedure and were then followed for one year. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Year 1 |
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Throughout study to Year One
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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 | Mild Procedure | percutaneous decompression with bone and tissue removal | 0 | 20 | 0 | 20 | ||
| EG001 | Sham Procedure With Optional Crossover to Mild Post-unblinding | Sham procedure includes percutaneous trocar placement with no tissue or bone removal. | 0 | 20 | 0 | 20 |
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This was a small series with challenging patient retention, particularly in the sham arm.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Grigsby, MD | Napa Pain Institute | 707-252-9660 | egrig@aol.com |
| Withdrawal by Subject |
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| pancreatic cancer progressed |
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| >=65 years |
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| Male |
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