Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

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.

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Key information

Conditions

Pain Chronic Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Delta vzw, Roeselare, West Flanders, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 to treat chronic pain at one anatomical region
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 and localized pain with extension/lateral bending
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

Subject has sacroiliac joint pain based on medical history and physical exam
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

Subject has radicular pain based on medical history and physical exam
Subject has radicular pain confirmed by dermatomal mapping corresponding to at least 1 nerve root level

E. Candidate subjects with trigeminal neuralgia

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

F. Candidate subjects with knee or hip pain

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

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

Subject has sensory problems

Treatment and study plan

IonicRF Generator and compatible accessories

Device

Participants will receive IonicRF lesion generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator

Primary outcomes

Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit

Time frame: Baseline to 3 months

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. The presented outcome denotes the mean relative change in NRS score, which was defined as (Baseline score - 3-month follow-up visit score)/ Baseline score*100%. Higher scores indicate greater relative pain relief. Minimum value is 0% and maximum value is 100%.
Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events

Time frame: At 3 months

Number of participants with Device- and Procedure-related Serious Adverse Events.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: ROSTRA

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: May 5, 2021
Registry last updated: Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed