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.
Study Type
OBSERVATIONAL
Enrollment
184
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
Nura
Edina, Minnesota, United States
Nevada Advanced Pain Specialists
Reno, Nevada, United States
Ainsworth Institute of Pain Management
New York, New York, United States
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. 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%.
Time frame: Baseline to 3 months
Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events
Number of participants with Device- and Procedure-related Serious Adverse Events.
Time frame: At 3 months
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The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia, United States
AZ Delta vzw
Roeselare, West Flanders, Belgium
Hôpital Privé du Confluent
Nantes, Pays de la Loire Region, France
Krankenhaus Neuwerk Maria von den Aposteln
Mönchengladbach, N. RHIN, Germany
Universitätsmedizin Berlin - Charité Campus Mitte
Berlin, Germany
Stichting Rijnstate Ziekenhuis - Arnhem
Arnhem, Gelderland, Netherlands
Hospital Puerta del Mar
Cadiz, Spain
...and 1 more locations