Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation (ROSTRA)

Abbott

Status: Completed

Conditions: Pain

Treatments: Device: IonicRF Generator and compatible accessories

Study type: Observational

Funder types: Industry

Identifiers

NCT04873817

ABT-CIP-10347

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A. All candidate subjects

1. Subject must provide written informed consent prior to any clinical investigation-related procedure
2. Subject is ≥ 18 years of age
3. Subject has chronic pain > 6 months and was unresponsive to conservative management
4. Subject has pain on an NRS scale of ≥ 6
5. Subject is scheduled for an RFA procedure with the IonicRF generator within 30 days of baseline to treat chronic pain at one anatomical region
6. Subject has stable chronic pain medication use for 30 days
7. Subject is willing and able to comply with the prescribed follow-up evaluations

B. Candidate subjects with facet joint pain (lumbar or cervical)

1. Subject has unilateral or bilateral pain on para-spinal palpation and localized pain with extension/lateral bending
2. Subject has facet joint pain confirmed by at least 1 positive medial branch block with 0.5 mL or less of anesthetics (across at least 3 vertebral levels) 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 based on medical history and physical exam
2. Subject has sacroiliac joint pain confirmed by an infiltration 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 based on medical history and physical exam
2. Subject has radicular pain confirmed by dermatomal mapping corresponding to at least 1 nerve root level

E. Candidate subjects with trigeminal neuralgia

1. Subject has trigeminal pain based on medical history and physical exam
2. Subject did not have any mass effect or stroke causing trigeminal pain confirmed by MRI
3. Subject is ≥ 60 years of age in case of a neurovascular conflict

F. Candidate subjects with knee or hip pain

1. Subject has knee or hip pain based on medical history and physical exam
2. Subject has radiographically confirmed osteoarthritis of the hip or knee, or has chronic pain following joint arthroplasty

Exclusion criteria

A. All candidate subjects

1. Subject is currently participating in another clinical investigation that may confound the results of this study.
2. Ongoing systemic or local infection in the area of the procedure.
3. Recent use of anticoagulants or subject with coagulopathy.
4. Primary complaint of deafferentation pain.
5. 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.
6. Subject's opioid usage is > 90 morphine equivalents per day.

B. Candidate subjects with trigeminal neuralgia

1. Subject has sensory problems

Trial design

184 participants in 1 patient group

IonicRF Generator and compatible accessories

Description:

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.

Treatment:

Device: IonicRF Generator and compatible accessories