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Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

NCT04873817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184

Last updated 2024-11-20

Study results available
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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

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2022-12-16
Completion
2023-03-08
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Netherlands
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04873817 on ClinicalTrials.gov