CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 184 enrolled
Drug / intervention
IonicRF Generator and compatible accessoriesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04873817
NCT04873817N/ACompleted
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Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

Abbott Medical Devices·observational·Posted May 5, 2021·Updated Nov 20, 2024

In Brief

An observational study evaluating IonicRF Generator and compatible accessories for Pain. Completed, enrolled 184 participants across 11 sites in 6 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesBelgium, France, Germany, Netherlands, Spain, United States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 5, 2021
Enrollment StartJun 29, 2021
Primary CompletionDec 16, 2022
Study CompletionMar 8, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.2 years ago

Interventions

IonicRF Generator and compatible accessoriesdevice

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