Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation (ROSTRA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04873817|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2021
Last Update Posted : June 30, 2022
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.
|Condition or disease||Intervention/treatment|
|Pain||Device: IonicRF Generator andcompatible accessories|
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Official Title:||Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation|
|Actual Study Start Date :||June 29, 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
IonicRF Generator and compatible accessories
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
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
- 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.
- Primary Safety Endpoint: Incidence of device- and procedure-related serious adverse events [ Time Frame: At 3 months ]The device- and procedure-related serious adverse events will be summarized as frequency, proportion and number of events per patient years of follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873817
|United States, Minnesota|
|Edina, Minnesota, United States, 55435|
|United States, Nevada|
|Nevada Advanced Pain Specialists|
|Reno, Nevada, United States, 89511|
|United States, New York|
|Ainsworth Institute of Pain Management|
|New York, New York, United States, 10022|
|United States, West Virginia|
|The Spine & Nerve Center of St Francis Hospital|
|Charleston, West Virginia, United States, 25301|
|AZ Delta vzw|
|Roeselare, West Flanders, Belgium, 8800|
|Hôpital Privé du Confluent|
|Nantes, Pays De La Loire, France, 44200|
|Krankenhaus Neuwerk Maria von den Aposteln|
|Monchengladbach, N. Rhin, Germany, 41066|
|Universitätsmedizin Berlin - Charité Campus Mitte|
|Berlin, Germany, 10117|
|Stichting Rijnstate Ziekenhuis - Arnhem|
|Arnhem, Gelderland, Netherlands, 6815 AD|
|Hospital Puerta del Mar|
|Cadiz, Spain, 11009|
|Hospital Clínico Universitario de Valencia|
|Valencia, Spain, 46010|
|Study Director:||Brad Maruca||Abbott|