Radiation Free Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT06549348
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance — RADIATION
    Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance

Study Details

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)

Key Dates

Start date
Jul 3, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Task navigation using fluoroscopy guidance
    Standard of care treatment using
  • Active Comparator: Task navigation using LumiGuide
    Standard of care treatment using LumiGuide fluoroscopy guidance

Primary Outcome Measure

To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR). [ Time Frame: Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35249
Adam Beck (PRINCIPAL_INVESTIGATOR)
University of MassachusettsWorcesterMassachusetts01655
Andres Schanzer (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Darren Schneider (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Carlos Timaran (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALUniversity of Massachusetts· Worcester, MAUniversity of Pennsylvania· Philadelphia, PAUniversity of Texas Southwestern Medical Center· Dallas, TX

Related Studies