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Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | BVN Ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracept | Device | Radiofrequency ablation of the basivertebral nerve using the Intracept System |
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| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) - 3 Months | Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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 in ODI from baseline is considered to be a 10 points reduction from baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) - 3 Months | Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline. | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eeric Truumees, MD | Independent | Principal Investigator |
| Kevin Macadaeg, MD | Independent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Spine Group | Carmel | Indiana | 46032 | United States | ||
| Seton Spine and Scoliosis Center |
Results
At the completion of trial
Written request to study sponsor
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Patients for the study were drawn from current low back pain clinic populations, referrals, and patient self-referral at two investigative sites in the U.S. from February 2018 to February 2019. Consecutively identified patients were screened for medical history and review of MRI for Modic/endplate changes and any excluded pain sources.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Intracept - Intraosseous radiofrequency ablation of the basivertebral nerve using the Intracept System |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment to Procedure |
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| 3-Month Follow-up Visit |
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| 12-Month Follow-up Visit |
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Intracept treated population
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Intracept Intracept: Radiofrequency ablation of the basivertebral nerve using the Intracept System |
| 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 |
| 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 | Oswestry Disability Index (ODI) - 3 Months | Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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 in ODI from baseline is considered to be a 10 points reduction from baseline. | Basivertebral nerve ablation treated participants | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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12 months
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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 | Treatment | BVN Ablation Radiofrequency ablation of the basivertebral nerve using the Intracept System |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiculitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Transient leg pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Affairs | Relievant Medsystems Inc. | (650) 368-1000 | 280 | dsahr@relievant.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 | Nov 15, 2018 | Nov 2, 2020 | Prot_SAP_000.pdf |
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| ODI Responder Rate - 3-Month |
Number & percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. ODI is scored 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 10 points. |
| 3 Months |
| VAS Responder Rate - 3 Month | Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction. | 3 Months |
| ODI -12 Months | Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. 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 10 point reduction in ODI. | 12 Months |
| VAS - 12 Month | Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction. | 12 Months |
| ODI Responder Rate - 12-Month | Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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 10 points. | 12 Months |
| VAS Responder Rate - 12 Months | Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score. | 12 Months |
| VAS Reduction 50% or More - 12 Month | Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months. | 12 Months |
| Austin |
| Texas |
| 78731 |
| United States |
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| 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 | Number | participants |
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| Baseline Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is a validated questionnaire of low back pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points. | Mean | Standard Deviation | Total score on a scale of 0 to 100 |
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| Baseline Visual Analog Scale (VAS) for Low Back Pain | Visual Analog Scale (VAS) for low back pain is a patient-rated 10-point numeric scale with 0 being no pain and 10 being worst imaginable pain. | Mean | Standard Deviation | Scale 0 to 10 |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Visual Analog Scale (VAS) - 3 Months | Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline. | Basivertebral nerve ablation treated participants with a 3 month visit | Posted | Mean | Standard Deviation | units on a scale | 3 Months |
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| Secondary | ODI Responder Rate - 3-Month | Number & percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. ODI is scored 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 10 points. | Basivertebral nerve ablation treated participants with a 3 month visit | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | VAS Responder Rate - 3 Month | Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction. | Basivertebral nerve ablation treated participants with a 3 month follow-up visit | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | ODI -12 Months | Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. 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 10 point reduction in ODI. | Basivertebral nerve ablation treated participants with a 12 month visit | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
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| Secondary | VAS - 12 Month | Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction. | Basivertebral nerve ablation treated participants with 12-month follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
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| Secondary | ODI Responder Rate - 12-Month | Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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 10 points. | Basivertebral ablation treated participants with a 12 month follow-up visit | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | VAS Responder Rate - 12 Months | Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score. | Basivertebral nerve ablation treated participants with a 12 month follow-up visit | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | VAS Reduction 50% or More - 12 Month | Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months. | Basivertebral nerve ablation treated participants with a 12 month follow-up visit | Posted | Count of Participants | Participants | 12 Months |
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