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Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment.
The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up).
Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BVN Ablation | Active Comparator | BVN ablation with continued standard care |
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| Standard Care Control | Active Comparator | Continue with non-surgical standard care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracept System | Device | BVN ablation using radiofrequency energy |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) | Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS) | Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Garfin, MD | Independent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | United States | ||
| Barrow Brain and Spine |
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| Label | URL |
|---|---|
| INTRACEPT Study Website | View source |
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Trial results will be published at the completion of the trial
End of trial
To be determined
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420 patients screened for MRI Modic changes at levels L3 to S1 to achieve 140 enrollments. Patients with Modic changes at other levels or who had other primary etiologies for their low back pain (i.e. disc herniation, stenosis, facet joint) were excluded. An independent orthopedic surgeon medical reviewer confirmed eligibility prior to randomization. A pre-specified interim analysis was conducted when 60% of randomized patients completed their 3-month primary endpoint visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Basivertebral Nerve (BVN) Ablation | BVN ablation with non-surgical standard care Intracept System: BVN ablation |
| FG001 | Standard Care Control | Continue with non-surgical standard care |
| 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 | Oct 17, 2018 |
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BVN Ablation vs Standard Care Control
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| Standard Care |
| Other |
Non-surgical standard care |
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| 3 months post treatment / randomization |
| Phoenix |
| Arizona |
| 85048 |
| United States |
| Keck Medicine of USC | Los Angeles | California | 90033 | United States |
| Stanford Orthopaedic Surgery | Redwood City | California | 94063 | United States |
| Denver Back Specialists | Greenwood Village | Colorado | 80111 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30329 | United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| St Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Bassett Medical Center | Cooperstown | New York | 13326 | United States |
| University of Rochester | Rochester | New York | 14618 | United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Clinical Investigations | Edmond | Oklahoma | 73013 | United States |
| Pacific Sports and Spine | Eugene | Oregon | 97401 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Temple University | Philadelphia | Pennsylvania | 19147 | United States |
| Precision Spine Center | Tyler | Texas | 75701 | United States |
| Interim Analysis |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Basivertebral Nerve (BVN) Ablation | BVN ablation with standard care Intracept System: BVN ablation |
| BG001 | Standard Care Control | Continue standard care |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | 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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| Baseline Oswestry Disability Index (ODI) | Oswestry Disability Index (ODI) total score is on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction from baseline. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline Visual Analogue Scale (VAS) | Low Back Pain Visual Analog Scale (VAS). Participant indicated level of low back pain on a 10 point numeric scale with 0 being no pain and 10 being maximum pain. The published minimal clinically important difference for VAS is a 2 point reduction from baseline value. | Mean | Standard Deviation | units on a scale of 0 to 10 |
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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 | Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) | Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available. | Interim Analysis N=104 (pre-specified interim analysis when approximately 60% of randomized participants complete their 3-month primary endpoint | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 3 months |
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| Secondary | Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS) | Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available. | Interim Analysis population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 3 months post treatment / randomization |
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Enrollment through 24 month follow-up
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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 | BVN Ablation | BVN ablation with continued standard care Intracept System: BVN ablation using radiofrequency energy | 0 | 66 | 0 | 66 | 16 | 66 |
| EG001 | Standard Care Control | Continue with non-surgical standard care Standard Care: Non-surgical standard care | 0 | 74 | 0 | 74 | 6 | 74 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Leg Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Temporary leg pain resolved in mean of 42 days |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment | Post anesthesia related urinary retention. Resolved with catheterization. |
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| Incisional Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Post procedure incision region discomfort |
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| Ongoing low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Disc Herniation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Incomplete Procedure | Musculoskeletal and connective tissue disorders | Systematic Assessment | Inability to access |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Hilker, Sr. Director Clinical Affairs | Relievant Medsystems | (650) 368-1000 | chilker@relievant.com |
| Oct 12, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| Asian |
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| 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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