Obsidio™ Conformable Embolic Registry

Recruiting

• Conditions: Hypervascular Tumors; Hemorrhage; Bleeding

• Registration Number: NCT06170619
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Study Start: 2024-06-19
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-27
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary effectiveness endpoint	Immediately following index procedure	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.
Primary safety endpoint	30 days following index procedure	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.

Trial Locations

Locations (20)

Mayo Clinic Hospital; 🇺🇸 Phoenix, Arizona, United States

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

St. Joseph's Medical Center; 🇺🇸 Stockton, California, United States

Christiana Hospital; 🇺🇸 Newark, Delaware, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Chicago Hospital; 🇺🇸 Chicago, Illinois, United States

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

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