COMPLETED

Obsidio™ Conformable Embolic Registry

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Conditions

Hypervascular TumorsBleedingHemorrhage

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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

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

Quick Facts

Study Start:2024-06-19
Study Completion:2025-09-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06170619

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 CriteriaExclusion Criteria
  1. * Patient is ≥ 18 years of age
  2. * Signed informed consent\*
  3. * Patient is to undergo or has undergone embolization with Obsidio™ Conformable Embolic
  4. * Patient is willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits \*Patients being treated for control of bleeding/hemorrhage who are unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hours of the index procedure
  1. * Patient has a life expectancy \< 30 days
  2. * Contraindications to receiving Obsidio™ Conformable Embolic per the Instructions For Use (IFU)
  3. * Embolization for uterine fibroids, prostate artery, genicular artery, ovarian vein, spermatic vein, pulmonary arteriovenous malformations, bronchial artery, asymptomatic benign tumors, portal vein, varices, lymphatic/thoracic duct, nonvascular channel (e.g. ureter, intestinal fistula)
  4. * Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels

Contacts and Locations

Study Locations (Sites)

Mayo Clinic Hospital
Phoenix, Arizona, 85054
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
United States
St. Joseph's Medical Center
Stockton, California, 95204
United States
Christiana Hospital
Newark, Delaware, 19718
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University of Chicago Hospital
Chicago, Illinois, 60637
United States
University of Kansas Hospital
Kansas City, Kansas, 66160
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Barnes Jewish Hosital
St Louis, Missouri, 63110
United States
University Hospital
Newark, New Jersey, 07103
United States
Albany Medical Center
Albany, New York, 12208
United States
Mount Sinai Medical Center
New York, New York, 10029
United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Texas Houston Health Science Center
Houston, Texas, 77030
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

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 Date2024-06-19
Study Completion Date2025-09-09

Study Record Updates

Study Start Date2024-06-19
Study Completion Date2025-09-09

Terms related to this study

Additional Relevant MeSH Terms

  • Hypervascular Tumors
  • Bleeding
  • Hemorrhage