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Evaluation of a Simple-Prep Controlled Embolic

NCT06453642 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Embolization
  • Vascular Tumor
  • Renal Angiomyolipoma
  • Renal Cell Carcinoma
  • Bone Tumor
  • Portal Vein Embolization

Interventions

DEVICE

GPX® Embolic Device

Treatment includes distal embolization in the peripheral vasculature of vascular tumors, renal embolization, and portal vein branches

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Fluidx Medical Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Darcy, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2026-05-31
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States
  • Canada
  • New Zealand

Study Locations

More Related Trials

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 NCT06453642 on ClinicalTrials.gov