Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873817
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2021-05-04
Brief Title:
Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROSTRA
Brief 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 Abbotts IonicRFGenerator 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None