Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
Signed a valid, IRB/EC-approved informed consent form.
Disqualifiers
Meets any contraindications per locally applicable Instructions for Use (IFU).
Trial population
Subjects are established patients in a medical practice who will receive intraosseous nerve ablation to treat vertebrogenic pain utilizing a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use according to standard of care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intracept™ Intraosseous Nerve Ablation
DeviceIntracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Intracept™ Intraosseous Nerve Ablation Systems1 intervention
Trial outcomes
Primary outcomes
1
Change in Disability (Oswestry Disability Index (ODI) from Baseline
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.
Time frame
60-months post-procedureSponsors and contacts
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Source ClinicalTrials.gov