Obsidio™ Conformable Embolic Registry

NCT06170619 | Completed FDA Device

• 1 other identifier: S2513
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Hypervascular Tumors; Bleeding; Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Primary effectiveness endpoint

  The primary effectiveness endpoint is technical success, which is defined as occlusion of the target vessel(s) after embolization with Obsidio™ Conformable Embolic as assessed via angiography or demonstration of a cast of Obsidio occluding the artery on fluoroscopy or image acquisition immediately following the index procedure.

  Immediately following index procedure

• Primary safety endpoint

  The primary safety endpoint is freedom from major adverse events defined as non-target embolization events that meet serious adverse event criteria, unintended target organ or soft tissue infarction, vessel perforation/injury and catheter entrapment through 30 days of the index procedure.

  30 days following index procedure

Study Arms (1)

All subjects

Device: Obsidio™ Conformable Embolic

Interventions

Obsidio™ Conformable Embolic DEVICE

Embolization with Obsidio™ Conformable Embolic.

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo or have undergone embolization with Obsidio™ Conformable Embolic

You may qualify if:

• Patient is ≥ 18 years of age
• Signed informed consent\*
• 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 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

You may not qualify if:

• 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, portal vein, varices, lymphatic/thoracic duct, nonvascular channel (e.g. ureter, intestinal fistula)
• Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (20)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

St. Joseph's Medical Center

Stockton, California, 95204, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Barnes Jewish Hosital

St Louis, Missouri, 63110, United States

Location

University Hospital

Newark, New Jersey, 07103, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Texas Houston Health Science Center

Houston, Texas, 77030, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: June 19, 2024
• Primary Completion: September 9, 2025
• Study Completion: September 9, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)