Clinical trial NCT04873817: Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
Official title: Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: IonicRF™ Generator
ABT-CIP-10347
Radio frequency ablation (RFA)
Chronic pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of all genders from the general chronic pain population referring to the participating pain clinics will be enrolled in the study.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit
timeFrame: Baseline to 3 months
measure: Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events
timeFrame: At 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edina
country: United States
facility: Nura
state: Minnesota
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Charleston
country: United States
facility: The Spine & Nerve Center of St Francis Hospital
state: West Virginia
city: Roeselare
country: Belgium
facility: AZ Delta vzw
state: West Flanders
city: Nantes
country: France
facility: Hôpital Privé du Confluent
state: Pays De La Loire
city: Monchengladbach
country: Germany
facility: Krankenhaus Neuwerk Maria von den Aposteln
state: N. Rhin
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Charité Campus Mitte
city: Arnhem
country: Netherlands
facility: Stichting Rijnstate Ziekenhuis - Arnhem
state: Gelderland
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References: