Obsidio™ Conformable Embolic Registry

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypervascular Tumors Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Hospital, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obsidio™ Conformable Embolic

Device

Embolization with Obsidio™ Conformable Embolic.

Primary outcomes

Primary effectiveness endpoint

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: OCCLUDE

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 14, 2023
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed