Trials / Recruiting
RecruitingNCT06549348
Radiation Free Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- Sponsor
- Philips Clinical & Medical Affairs Global · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable. Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance | Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance |
Timeline
- Start date
- 2025-07-03
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2024-08-12
- Last updated
- 2025-09-05
Locations
9 sites across 6 countries: United States, Belgium, Denmark, France, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06549348. Inclusion in this directory is not an endorsement.