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Recruiting NCT06742801

Onyx™ Liquid Embolic IDE Clinical Study

No phase Interventional Peripheral Arterial Hemorrhage Trauma GI Bleed Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Onyx™ Liquid Embolic System.
Who it may be relevant to
Registry conditions: Peripheral Arterial Hemorrhage, Trauma, GI Bleed, Ulcer. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature

Overview

The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.

Detailed description

This is a pivotal, prospective, multi-center, non-randomized, single arm study. This study will enroll patients with active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by investigator. In this study, peripheral vasculature is defined as outside of the brain and heart.

Up to 135 subjects will be consented to achieve 119 enrolled at up to 25 sites in the US.

This study will have two visits post-index procedure including hospital discharge visit and 30-day follow-up visit. Reintervention visits will be captured through 30 days post-index procedure.

Interventions

  • Device Onyx™ Liquid Embolic System
    The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.

Primary outcome measures

  • Freedom from Arterial Hemorrhage [Time frame: Through 30 days post-index procedure]
  • Freedom from System-related Major Adverse Events (MAE) [Time frame: Through 30 days post-index procedure]
Secondary outcome measures (4)
  • Procedural Success [Time frame: At the completion of the index procedure]
  • Technical Success [Time frame: At the completion of the index procedure]
  • Reintervention [Time frame: Through 30 days post-index procedure]
  • Transfusions [Time frame: Through 30 days post-index procedure]

Eligibility criteria

Inclusion criteria

  • Patient is ≥ 22 years old.
  • Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.

In this study, peripheral vasculature is defined as outside the brain and heart.

  • Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
  • Life expectancy of >30 days, in the opinion of the investigator at the time of enrollment.
  • Target treatment area is free from prior embolization treatment.

Exclusion criteria

  • Pregnant or breastfeeding.
  • Symptoms of active infection.
  • Patient is known to be participating in the study of an investigational drug, biologic, or device.
  • Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
  • Known allergy to components of Onyx™.
  • Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
  • More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 18 centers
  • Mayo Clinic — Phoenix
  • University of California, Irvine — Irvine
  • Stanford Medical Center — Palo Alto
  • UCHealth University of Colorado Hospital — Aurora
  • Yale New Haven — New Haven
  • University of Chicago — Chicago
  • University of Iowa Hospitals and Clinics — Iowa City
  • Masschusetts General Hospital — Boston
  • … and 10 more centers

Identifiers

NCT: NCT06742801 · MDT21044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗