Trials / Completed
CompletedNCT04873817
Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 184 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IonicRF Generator and compatible accessories | 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 |
Timeline
- Start date
- 2021-06-29
- Primary completion
- 2022-12-16
- Completion
- 2023-03-08
- First posted
- 2021-05-05
- Last updated
- 2024-11-20
- Results posted
- 2024-11-20
Locations
11 sites across 6 countries: United States, Belgium, France, Germany, Netherlands, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04873817. Inclusion in this directory is not an endorsement.