RECRUITING

Evaluation of a Simple-Prep Controlled Embolic

Conditions

Embolism Vascular Tumor Renal Angiomyolipoma Renal Cell Carcinoma Bone Tumor Portal Vein Embolism Embolization Distal Embolization Distal Vessel Penetration Peripheral Vasculature

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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

The objective of this study is to evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration in 114 subjects in up to 25 investigational sites in the USA, New Zealand, and Canada.

Official Title

Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)

Quick Facts

Study Start:2024-11-18

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06453642

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
1. Age ≥18 years on the date of consent 2. Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits 3. Presents with need for peripheral embolization where there is a desire for distal vessel bed penetration including: * Vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors) * Renal embolization * Portal vein branches 4. Informed consent granted by the patient or legally authorized representative 5. Willing and able to comply with the protocol-specified procedures and assessments	1. Requires embolization for any of the following applications: a) Neurovasculature b) Coronary vasculature c) Hemorrhage due to trauma d) Non-tumoral focal/active bleeding sites (e.g., gastrointestinal tract, urinary tract, lung) e) Veins other than portal vein f) Aneurysms g) Endoleaks h) Vascular malformations i) Vessels for flow redistribution 2. Has undergone an embolization procedure within 30 days prior to consent 3. Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine) 4. Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents) 5. Known allergy or hypersensitivity to contrast media that cannot be adequately medicated 6. Pregnant, planning to become pregnant during the study period, or breastfeeding 7. Unresolved systemic infection or localized infection in the targeted region 8. Pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the investigator, would clinically confound the study primary endpoints 9. Existing medical condition which, in the opinion of the investigator, may cause the subject to be intolerant of an occlusion procedure or non-compliant with the protocol or may confound the data interpretation 10. Subject is participating in another device, drug, or procedure clinical investigation and has not completed the study treatment or the other investigation clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints) 11. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 12. Patients with drug or alcohol dependency (within 6 months prior to study entry) that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years on the date of consent
2. Expected post-procedural lifespan of at least 30 days, in the opinion of the investigator, to allow for participation in all follow-up visits
3. Presents with need for peripheral embolization where there is a desire for distal vessel bed penetration including:
* Vascular tumors (e.g., renal angiomyolipoma, renal cell carcinoma, bone tumors, bleeding tumors, and other vascular tumors)
* Renal embolization
* Portal vein branches
4. Informed consent granted by the patient or legally authorized representative
5. Willing and able to comply with the protocol-specified procedures and assessments

1. Requires embolization for any of the following applications: a) Neurovasculature b) Coronary vasculature c) Hemorrhage due to trauma d) Non-tumoral focal/active bleeding sites (e.g., gastrointestinal tract, urinary tract, lung) e) Veins other than portal vein f) Aneurysms g) Endoleaks h) Vascular malformations i) Vessels for flow redistribution
2. Has undergone an embolization procedure within 30 days prior to consent
3. Presents with need for embolization where the risk of clinically significant infarction outweighs the benefit of distal penetration (e.g., gastrointestinal, uterine)
4. Embolization target is only intended for temporary occlusion (e.g., bioresorbable biologic embolic agents)
5. Known allergy or hypersensitivity to contrast media that cannot be adequately medicated
6. Pregnant, planning to become pregnant during the study period, or breastfeeding
7. Unresolved systemic infection or localized infection in the targeted region
8. Pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the investigator, would clinically confound the study primary endpoints
9. Existing medical condition which, in the opinion of the investigator, may cause the subject to be intolerant of an occlusion procedure or non-compliant with the protocol or may confound the data interpretation
10. Subject is participating in another device, drug, or procedure clinical investigation and has not completed the study treatment or the other investigation clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)
11. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults) 12. Patients with drug or alcohol dependency (within 6 months prior to study entry) that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results

Contacts and Locations

Study Contact

Libble Ginster

CONTACT

435-893-1555

Libble.Ginster@fluidxmedical.com

Michelle Doyle, PhD

CONTACT

720-201-0530

michelle.doyle@brightresearch.com

Principal Investigator

Michael Darcy, MD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Indiana University Hospital

Indianapolis, Indiana, 46202

United States

Washington University - Barnes Jewish Hospital

Saint Louis, Missouri, 63110

United States

MD Anderson Cancer Center - Interventional Radiology

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Fluidx Medical Technology, Inc.

Michael Darcy, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Date2024-11-18

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-11-18

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

Embolization
Distal Embolization
Distal Vessel Penetration
Peripheral Vasculature

Additional Relevant MeSH Terms

Embolism
Vascular Tumor
Renal Angiomyolipoma
Renal Cell Carcinoma
Bone Tumor
Portal Vein Embolism