Onyx™ Liquid Embolic IDE Clinical Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Medtronic Endovascular
Study ID
NCT06742801
Status
Recruiting
Apply to this trial

Conditions

  • GI Bleed
  • Hemorrhage
  • Peripheral Arterial Hemorrhage
  • Trauma
  • Ulcer

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
May 9, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
119 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Onyx LES
    Device; embolization with liquid embolic

Primary Outcome Measure

Freedom from Arterial Hemorrhage [ Time Frame: Through 30 days post-index procedure ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
Debbie Ryan
[email protected]
480-342-1208
Xavier Lopez
Sadeer Alzubaidi, MD (PRINCIPAL_INVESTIGATOR)
University of California, IrvineIrvineCalifornia92627
Nadine Jaoudeh, MD
[email protected]
Bryan Robles
[email protected]
Stanford Medical CenterPalo AltoCalifornia94304
Andrew Picel, MD
Meredith Durbahn
UCHealth University of Colorado HospitalAuroraColorado80045
Alejandra Aguilar, MPH
[email protected]
Eduardo Bent Robinson, MD (PRINCIPAL_INVESTIGATOR)
Yale New HavenNew HavenConnecticut06510
Angelo Marino, MD
[email protected]
Patricia Fugal
[email protected]
University of ChicagoChicagoIllinois60637
Tiana Jackson
[email protected]
Brian Funaki, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Judith Pena Quevedo, AGNP-C, CCRC
Michael Hummel, MD (PRINCIPAL_INVESTIGATOR)
Masschusetts General HospitalBostonMassachusetts02114
Vincent Wu, MD
[email protected]
Justin Hill
[email protected]
CHI Health Creighton University Medical Center-Bergan-MercyOmahaNebraska68124
Janice Mitchel
[email protected]
402-619-9402
Patrick Harty (PRINCIPAL_INVESTIGATOR)
Rutgers New Jersey Medical SchoolNewarkNew Jersey07103
Saharsh Patel
[email protected]
Abhishek Kumar, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical CenterAlbanyNew York12208
Gary Siskin, MD
[email protected]
Nancy Spencer, NP
[email protected]
The Mount SinaiNew YorkNew York10029
Rajesh Patel, MD
[email protected]
Aaron Greenberg
[email protected]
University Hospitals Cleveland Medical CenterClevelandOhio44106
Salim Abboud, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Mina Makary, MD
Tamara Stein
[email protected]
University of Pittsburgh Medical CenterPittsburghPennsylvania15237
Suzanne Burdin
[email protected]
Paula Novelli, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37212
Celia Nunez
[email protected]
615-322-4559
Anthony Borgmann, MD (PRINCIPAL_INVESTIGATOR)
Univ Of Texas SouthwesternDallasTexas75235
Camille Harry
[email protected]
214-648-8986
Sanjeeva Kalva, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77030
Praneeth Nadimpalli
[email protected]
Lauren McGuire, RN
[email protected]
Rodrick Zvavanjanja, MD (PRINCIPAL_INVESTIGATOR)

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