RECRUITING

Radiation Free Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Radiation Free Study

Quick Facts

Study Start:2025-07-03

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06549348

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including subjects with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the repair. * Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law. * Subject has a life expectancy of at least 2 years * Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries	* Subjects undergoing an endovascular procedure that include branches or iliac branched devices (IBD) in the repair * Subject treated for re-intervention / staged procedure post-primary FEVAR procedure * Subjects intended to be treated for more than 4 target vessels (not counting the contralateral gate) * Subject treated for an emergent (\<24hrs after emergence) procedure * Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome * Subject with contrast allergies * Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips. * All vulnerable subjects such as immuno-compromised subjects, subjects lacking the capacity to provide consent, patients in emergency situations, pregnant or breast-feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any. * Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent

Inclusion Criteria

Exclusion Criteria

* Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including subjects with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the repair.
* Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law.
* Subject has a life expectancy of at least 2 years
* Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries

* Subjects undergoing an endovascular procedure that include branches or iliac branched devices (IBD) in the repair
* Subject treated for re-intervention / staged procedure post-primary FEVAR procedure
* Subjects intended to be treated for more than 4 target vessels (not counting the contralateral gate)
* Subject treated for an emergent (\<24hrs after emergence) procedure
* Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome
* Subject with contrast allergies
* Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips.
* All vulnerable subjects such as immuno-compromised subjects, subjects lacking the capacity to provide consent, patients in emergency situations, pregnant or breast-feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any.
* Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent

Contacts and Locations

Study Contact

Bart Wessels

CONTACT

bart.wessels@philips.com

Study Locations (Sites)

University of Alabama

Birmingham, Alabama, 35249

United States

University of Massachusetts

Worcester, Massachusetts, 01655

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: Philips Clinical & Medical Affairs Global

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-03

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-07-03

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Aortic Aneurysm