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To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superion™ IDS | All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superion™ IDS | Device | All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low Back Pain Responder Rate | Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) | Up to 3 years post-procedure |
| Left Leg Pain Responder Rate | Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) | Up to 3 years post-procedure |
| Right Leg Pain Responder Rate | Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) | Up to 3 years post-procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Low Back Pain Relief | Percent Low Back Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR). PPR is a questionnaire assessing how much of the subject's low back pain has been relieved by treatment. Pain relief is expressed as a percentage from 0 - 100%. | Up to 3 years post-procedure |
Key Inclusion Criteria:
Key Exclusion Criteria:
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Subjects with moderate Lumbar Spinal Stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Medicine Associates | Fountain Valley | California | 92708 | United States | ||
| California Orthopedics & Spine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Superion™ IDS | All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms. Superion™ IDS: All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 2, 2022 |
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| Quality of Life (QoL) |
Percent of change from Baseline index score to the Follow-up timepoints index score using EQ-5D-5L. EuroQol Five Dimensions Five Level questionnaire (EQ-5D-5L) is comprised of a descriptive system and a visual analog scale (VAS). The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. VAS is used to record the subject's self-rated health on a 20cm vertical line with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. To calculate the Index Value, responses are converted into a single score using a specific algorithm. Score ranges from 0.000 (representing death) to 1.000 (representing perfect health). The algorithm is based on public preferences, reflecting how different health states are valued by the general public. |
| Up to 3 years post-procedure |
| Larkspur |
| California |
| 94939 |
| United States |
| Relieve Pain Center, Inc. | San Diego | California | 92103 | United States |
| Source Healthcare | Santa Monica | California | 90403 | United States |
| Pacific Research Institute | Santa Rosa | California | 95403 | United States |
| IPM Medical Group Inc | Walnut Creek | California | 94598 | United States |
| Holy Cross Hospital Inc. | Fort Lauderdale | Florida | 33308 | United States |
| Louis J. Raso, MD, PA | Jupiter | Florida | 33477 | United States |
| Florida Pain Institute | Merritt Island | Florida | 32953 | United States |
| Southwest Florida Pain Center | Port Charlotte | Florida | 33948 | United States |
| Georgia Pain and Spine Care, Inc. | Newnan | Georgia | 30265 | United States |
| Centurion Spine and Pain Centers | Waycross | Georgia | 31501 | United States |
| North Idaho Day Surgery LLC | Post Falls | Idaho | 83854 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| KC Pain Centers | Lee's Summit | Missouri | 64086 | United States |
| Comprehensive and Interventional Pain Management LLP | Henderson | Nevada | 89052 | United States |
| Premier Pain Center | Shrewsbury | New Jersey | 07702 | United States |
| University Clinical Research Center | Somerset | New Jersey | 08873 | United States |
| The Toledo Clinic | Toledo | Ohio | 43623 | United States |
| Center for Interventional Pain and Spine | Bryn Mawr | Pennsylvania | 19010 | United States |
| Advanced Spine Pain Solution | Laredo | Texas | 78041 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
All subjects who completed the baseline information. Two subjects were consented but did not complete the baseline information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Superion™ IDS | All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms. Superion™ IDS: All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Low Back pain/symptoms | Percentage of patients with low back pain/symptoms | Count of Participants | Participants |
|
| 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 | Low Back Pain Responder Rate | Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) | Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS). Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively. | Posted | Count of Participants | Participants | Up to 3 years post-procedure |
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|
| |||||||||||||||||||||||||||||||||||
| Primary | Left Leg Pain Responder Rate | Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) | Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS). Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively. | Posted | Count of Participants | Participants | Up to 3 years post-procedure |
| |||||||||||||||||||||||||||||||||||||
| Primary | Right Leg Pain Responder Rate | Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) | Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS). Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively. | Posted | Count of Participants | Participants | Up to 3 years post-procedure |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Low Back Pain Relief | Percent Low Back Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR). PPR is a questionnaire assessing how much of the subject's low back pain has been relieved by treatment. Pain relief is expressed as a percentage from 0 - 100%. | No patients completed the percent pain relief at 2 and 3-Year Follow-up Visits. Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS). Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively. | Posted | Mean | Standard Deviation | percentage of low back pain relief | Up to 3 years post-procedure |
|
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Quality of Life (QoL) | Percent of change from Baseline index score to the Follow-up timepoints index score using EQ-5D-5L. EuroQol Five Dimensions Five Level questionnaire (EQ-5D-5L) is comprised of a descriptive system and a visual analog scale (VAS). The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. VAS is used to record the subject's self-rated health on a 20cm vertical line with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. To calculate the Index Value, responses are converted into a single score using a specific algorithm. Score ranges from 0.000 (representing death) to 1.000 (representing perfect health). The algorithm is based on public preferences, reflecting how different health states are valued by the general public. | No patients completed EQ5D-5L at 2 and 3 year visits. Intent-to-Treat (ITT) Population: Patients who receive treatment with the Superion® Indirect Decompression System (IDS). Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes data which was collected retrospectively. | Posted | Mean | Standard Deviation | percent change of score on a scale | Up to 3 years post-procedure |
|
From the time a subject sign the PRESS 2 Study Informed Consent through 3-year visit or study withdrawal. Patients include previously implanted subjects and newly enrolled subjects up to 3 years post-procedure. Data for patients previously implanted includes retrospective data however adverse events were monitored/assess from the time a subject signed the PRESS 2 Study Informed Consent through study completion.
Other (Not including Serious) Adverse Events definition differs from clinicaltrials.gov results Data Element definition - Per the study protocol, only device hardware and/or procedure related adverse events were monitored/assessed. Other, non-serious adverse events not related to the device hardware and/or procedure were not collected or assessed in this study.
All Serious Adverse Events and All-Cause Mortality were monitored/assessed per the clinicaltrials.gov definition.
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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 | Superion™ IDS | All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms. Superion™ IDS: All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms. | 0 | 129 | 12 | 129 | 3 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Spinal operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Deep Vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Purulent discharge | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Boston Scientific Corporation | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Aug 15, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Caucasian |
|
| Hispanic or Latino |
|
| Other |
|
| Not disclosed |
|
| OG003 |
| Superion™ IDS 3-Year Follow-up |
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit. |
|
|
| OG003 |
| Superion™ IDS 3-Year Follow-up |
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 3-Year Visit. |
|
|
| Participants |
|
|
| OG001 |
| Superion™ IDS 1-Year Follow-up |
All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms and completed 1-Year Visit. |
|
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