Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

Study Overview
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Brief Summary
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ROSTRA is an international, prospective, non-randomized, single-arm, multi-center, and post-market study to collect real-world safety and effectiveness data on Abbott's IonicRF™Generator and compatible RFA accessories. This post-market study is intended to satisfy EU MDR requirements. The study will enroll up to 180 subjects at up to 10 sites in Europe and the United States. The total duration of the study is expected to be 19 months, including enrollment, data collection from all subjects, and study closeout.

Official Title
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Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

Conditions
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Pain

Intervention / Treatment
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* Device: IonicRF Generator andcompatible accessories


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. All candidate subjects Subject must provide written informed consent prior to any clinical investigation-related procedure Subject is ≥ 18 years of age Subject has chronic pain > 6 months and was unresponsive to conservative management Subject has pain on an NRS scale of ≥ 6 Subject is scheduled for an RFA procedure with the IonicRF generator within 30 days of baseline Subject has stable chronic pain medication use for 30 days Subject is willing and able to comply with the prescribed follow-up evaluations B. Candidate subjects with facet joint pain (lumbar or cervical) Subject has unilateral or bilateral pain on para-spinal palpation Subject has facet joint pain confirmed by at least 1 positive medial branch block with 0.5 mL or less of anesthetics achieving at least 50% pain relief, with real-time injection of radiographic contrast under fluoroscopic guidance C. Candidate subjects with sacroiliac joint pain 1. Subject has sacroiliac joint pain confirmed by an infiltration (with bony contact on 3 vertebral levels) of local anesthetics in the posterior part of the sacroiliac joint achieving at least 50% pain relief D. Candidate subjects with radicular pain 1. Subject has radicular pain confirmed by sensory mapping across at least 1 vertebral level E. Candidate subjects with trigeminal neuralgia Subject has trigeminal pain elicited using a provocation test (e.g. contact with toothbrush) Subject has sudden, non-continuous pain Subject did not have any mass effect or stroke causing trigeminal pain confirmed by MRI Subject has attempted anti-neuropathic medication with no improvement of symptoms F. Candidate subjects with knee or hip pain Subject has radiographically confirmed osteoarthritis of the hip or knee, or has chronic pain following joint arthroplasty Subject has knee or hip pain confirmed by sensory mapping and/or diagnostic block(s) Exclusion Criteria: A. All candidate subjects Subject is currently participating in another clinical investigation that may confound the results of this study. Ongoing systemic or local infection in the area of the procedure. Recent use of anticoagulants or subject with coagulopathy. Primary complaint of deafferentation pain. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results. Subject's opioid usage is > 90 morphine equivalents per day. B. Candidate subjects with trigeminal neuralgia 1. Subject has sensory problems

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IonicRF Generator and compatible accessories<br>IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used. | Device: IonicRF Generator andcompatible accessories<br>* Participants will recieve IonicRFRF lesion generator, along with any country-specific market-released accessory (i.e. electrode,cannula, grounding pad, and adaptor cable) compatible with theIonicRF Generator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary effectiveness endpoint: Relative change in Numeric Rating Scale (NRS) from baseline to 3 months follow-up visit | The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity. | Baseline to 3 months | 
| Primary Safety Endpoint: Incidence of device- and procedure-related serious adverse events | The device- and procedure-related serious adverse events will be summarized as frequency, proportion and number of events per patient years of follow-up. | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IonicRF™ Generator, ABT-CIP-10347, Radio frequency ablation (RFA)