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NCT04873817 · ClinicalTrials.gov registry record
Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 184
- Enrollment target
NCT04873817: Completed study, sponsored by Abbott Medical Devices.
NCT04873817 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 184 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04873817 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 184 participants
- Enrollment target
Study 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.
Primary Outcome
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 grea
Interventions
- DEVICE IonicRF Generator and compatible accessories
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2023-03-08 |
What the finished NCT04873817 record still lists
NCT04873817 is an observational study that tracks outcomes without assigning an intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which IonicRF Generator and compatible accessories is the first listed.
NCT04873817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04873817 about?
NCT04873817 is a clinical study titled "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.
What is the current status of trial NCT04873817?
This trial is currently completed. The enrollment target is 184 participants. The study started on 2021-06-29. Estimated completion is 2023-03-08.
What interventions are being tested in trial NCT04873817?
The interventions under investigation include: IonicRF Generator and compatible accessories (DEVICE).
Who is sponsoring clinical trial NCT04873817?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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