Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Siddarth Padia, MD (ucla)

Description

Summary

OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio.

Official Title

A Prospective, Post-Approval, Open-Label, Multi-Center United States (US) Registry to Evaluate the Effectiveness and Safety of Obsidio in Clinical Practice

Keywords

Hypervascular Tumors, Bleeding, Hemorrhage, Obsidio™ Conformable Embolic

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥ 18 years old
  • Patient has the ability to comprehend and willingness to sign the informed consent form. Patients being treated for control of bleeding /hemorrhage unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hrs. of the index procedure
  • Patient is to undergo or has undergone embolization with Obsidio™ Conformable Embolic
  • Patient is willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow up visit

You CAN'T join if...

  • Patient refuses participation
  • Patient has a life expectancy < 30 days
  • Contraindications to receiving Obsidio™ Conformable Embolic per the Instructions For Use (IFU)
  • Embolization for uterine fibroids, prostate artery, genicular artery, ovarian vein, spermatic vein, pulmonary arteriovenous malformations, bronchial artery, asymptomatic benign tumors
  • Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels

Locations

  • Ronald Reagan UCLA Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • St. Joseph's Medical Center not yet accepting patients
    Stockton California 95204 United States
  • Mercy Hospital accepting new patients
    Coon Rapids Minnesota 55433 United States
  • MedStar Georgetown University Hospital accepting new patients
    Washington District of Columbia 20007 United States

Lead Scientist at University of California Health

  • Siddarth Padia, MD (ucla)
    HS Clinical Professor, Radiological Sciences, Medicine. Authored (or co-authored) 85 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT06170619
Study Type
Observational [Patient Registry]
Participants
Expecting 125 study participants
Last Updated