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NCT05207813 · ClinicalTrials.gov registry record
CLBP Single-Arm Long-Term Follow-up Study
A clinical trial, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- 42
- Enrollment target
NCT05207813: Completed study, sponsored by Boston Scientific Corporation.
NCT05207813 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 42 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05207813 has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
Study Summary
This is a prospective, noninterventional, observational post market data collection of long-term effectiveness and satisfaction outcomes for "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Study)" population at three (3), four (4), and five (5) years post Intracept Procedure. The working hypothesis is that data collected in this study will demonstrate safety, efficacy, durability and reproducibility of BVN ablation treatment outcomes out to 3, 4, and 5-years post-procedure.
Primary Outcome
The Oswestry Disability Index (ODI) is a validated questionnaire of 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.
Interventions
- DEVICE Intracept Procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-02-16 |
| Est. Completion | 2024-02-01 |
What the finished NCT05207813 record still lists
NCT05207813 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Intracept Procedure is the first listed.
NCT05207813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05207813 about?
NCT05207813 is a clinical study titled "CLBP Single-Arm Long-Term Follow-up Study". This is a prospective, noninterventional, observational post market data collection of long-term effectiveness and satisfaction outcomes for "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Study)" p...
What is the current status of trial NCT05207813?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2022-02-16. Estimated completion is 2024-02-01.
What interventions are being tested in trial NCT05207813?
The interventions under investigation include: Intracept Procedure (DEVICE).
Who is sponsoring clinical trial NCT05207813?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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