Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superion® Indirect Decompression System (IDS) | Superion® Indirect Decompression System (IDS) - Interspinous Spacer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superion® Indirect Decompression System (IDS) | Device | Superion® Indirect Decompression System (IDS) (Superion® implant) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vertiflex® Patient Satisfaction Survey | Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%. | 3 Week Follow-Up Visit |
| Vertiflex® Patient Satisfaction Survey | Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%. | 6 Month Follow-Up Visit |
| Vertiflex® Patient Satisfaction Survey | Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%. | 12 Month Follow-Up Visit |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| (ACT) Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| HOPE Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Superion® Indirect Decompression System (IDS) | Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2016 | Jun 6, 2022 |
Not provided
Not provided
Not provided
Not provided
| Phoenix |
| Arizona |
| 85018 |
| United States |
| HOPE Research Institute | Scottsdale | Arizona | 85018 | United States |
| NuVation Pain Group | Buena Park | California | 90621 | United States |
| Comprehensive Pain Physicians | Burbank | California | 91505 | United States |
| Coastal Pain and Spinal Diagnostics | Carlsbad | California | 92009 | United States |
| Pain Medicine Associates | Fountain Valley | California | 92708 | United States |
| Valley Pain Management | Fresno | California | 93720 | United States |
| Pain Consultants of San Diego | La Mesa | California | 91942 | United States |
| California Orthopedics & Spine | Larkspur | California | 94939 | United States |
| Remedy Pain Solutions, Inc. | Marina del Rey | California | 90292 | United States |
| Newport Beach Headache & Pain | Newport Beach | California | 92660 | United States |
| Pain Consultants of San Diego- Poway | Poway | California | 92064 | United States |
| Relieve Pain Center | San Diego | California | 92103 | United States |
| Paul Kim MD Pain Management | San Diego | California | 92108 | United States |
| San Diego Comprehensive Pain Management Center | San Diego | California | 92108 | United States |
| Source Healthcare | Santa Monica | California | 90403 | United States |
| Evolve Restorative Center | Santa Rosa | California | 95403 | United States |
| Innovative Pain Treatment Solutions | Temecula | California | 92590 | United States |
| Intergrated Pain Management Medical Group, Inc. | Walnut Creek | California | 94598 | United States |
| Front Range Pain Medicine | Fort Collins | Colorado | 80525 | United States |
| The Orthopaedic & Sports Medicine Center | Trumbull | Connecticut | 06611 | United States |
| International Spine Pain & Performance Center | Washington D.C. | District of Columbia | 20006 | United States |
| Southeast Spine Associates | Fort Lauderdale | Florida | 33308 | United States |
| Holy Cross Interventional Spine and Pain Medicine | Fort Lauderdale | Florida | 33334 | United States |
| Jacksonville Spine Center | Jacksonville | Florida | 32256 | United States |
| Jupiter Interventional Pain Management | Jupiter | Florida | 33477 | United States |
| Florida Pain Institute | Merritt Island | Florida | 32953 | United States |
| Lake Nona Medical Arts | Orlando | Florida | 32827 | United States |
| Southwest Florida Pain Center | Port Charlotte | Florida | 33948 | United States |
| Florida Pain Management Associates | Sebastian | Florida | 32958 | United States |
| Tampa Pain Relief Center, Inc. | Tampa | Florida | 33613 | United States |
| The Spine Center of Southeast Georgia | Brunswick | Georgia | 31525 | United States |
| Georgia Pain and Spine Care | Newnan | Georgia | 30265 | United States |
| AXIS Spine Center | Coeur d'Alene | Idaho | 83815 | United States |
| AMITA Health Bolingbrook Pain Management Center | Bolingbrook | Illinois | 60440 | United States |
| Rush University Medical Center Department of Anesthesiology | Chicago | Illinois | 60612 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Neuroscience Research Center, LLC | Overland Park | Kansas | 66210 | United States |
| Pain Management Center of Paducah, KY | Paducah | Kentucky | 42003 | United States |
| Pain and Wellness | Cambridge | Massachusetts | 01960 | United States |
| Columbia Interventional Pain Center | Columbia | Missouri | 65203 | United States |
| Pain Management Associates | Lee's Summit | Missouri | 64086 | United States |
| Comprehensive and Interventional Pain Management | Henderson | Nevada | 89052 | United States |
| Advanced Pain Specialists | Reno | Nevada | 89511 | United States |
| Center for Pain Control at Jasper Ambulatory Surgical Center | Brick | New Jersey | 08723 | United States |
| Spine Institute of North America, LLC | East Windsor | New Jersey | 08520 | United States |
| Premier Pain Center | Shrewsbury | New Jersey | 07702 | United States |
| University Clinical Research Center | Somerset | New Jersey | 08873 | United States |
| Pain Management at Garden State Medical Center | Whiting | New Jersey | 08759 | United States |
| Upstate Orthopedics | East Syracuse | New York | 13057 | United States |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | United States |
| Cincinnati Comprehensive Pain Center | Cincinnati | Ohio | 45014 | United States |
| Dayton Outpatient Center | Dayton | Ohio | 45432 | United States |
| Summit Medical Center | Edmond | Oklahoma | 73013 | United States |
| Performance Spine & Sports Physicians, PC | East Norriton | Pennsylvania | 19403 | United States |
| Center for Interventional Pain & Spine | Exton | Pennsylvania | 19341 | United States |
| SC Pain and Spine | Murrells Inlet | South Carolina | 29576 | United States |
| North Lake Pain Consultants | Conroe | Texas | 77340 | United States |
| Performance Pain and Sports Medicine | Houston | Texas | 77027 | United States |
| Fondren Orthopedic Group, LLC | Kingwood | Texas | 77339 | United States |
| Advanced Spine and Pain Center | San Antonio | Texas | 78240 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| Southwest Spine and Pain | St. George | Utah | 84790 | United States |
| The Spine and Nerve Center of Saint Francis Hospital | Charleston | West Virginia | 25301 | United States |
| Advanced Pain Management | Greenfield | Wisconsin | 53221 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Data as available for study participants is reported.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Superion® Indirect Decompression System (IDS) | Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data was missing for 5 participants. Data as available for study participants is reported. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Baseline Pain Score | Baseline Pain score was collected on a scale of 0 -100 (VAS Scale) where 0 is no pain and 100 is worst pain possible. | Data is missing for 169 participants. Data as available for study participants is reported. | Mean | Standard Deviation | units on a scale |
|
| 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 | Vertiflex® Patient Satisfaction Survey | Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%. | Posted | Count of Participants | Participants | 3 Week Follow-Up Visit |
|
|
| |||||||||||||||||||||||||||
| Primary | Vertiflex® Patient Satisfaction Survey | Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%. | Posted | Count of Participants | Participants | 6 Month Follow-Up Visit |
|
| ||||||||||||||||||||||||||||
| Primary | Vertiflex® Patient Satisfaction Survey | Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%. | Posted | Count of Participants | Participants | 12 Month Follow-Up Visit |
|
|
Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.
Serious Adverse events (device or procedure related) up to 1 year follow up were only collected. Other adverse events not collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Superion® Indirect Decompression System (IDS) | Superion® Indirect Decompression System (IDS) - Interspinous Spacer Superion® Indirect Decompression System (IDS): Superion® Indirect Decompression System (IDS) (Superion® implant) | 1 | 1,674 | 5 | 1,674 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atelectasis (Post-Op) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Pain | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roshini Jain, Sr. Director Clinical Sciences | Boston Scientific | 16619494350 | roshini.jain@bsci.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
|
|