Okami Medical ALPHA Registry

N/AEnrolling By InvitationNCT07525518

Okami Medical, Inc.500 enrolled

Overview

This registry will provide insights into the use of Okami Medical devices in real-world clinical and study effectiveness and safety of Okami Medical devices.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Arterial Bleed Pulmonary Arteriovenous Malformation Embolization Hemorrhage

Interventions

LOBO Vascular Occlusion SystemDEVICE

LOBO Vascular Occlusion System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient or their legally authorized representative is willing and able to provide informed consent per local requirements * Has or will receive treatment with an eligible Okami Medical device * Age ≥ 18 years Exclusion Criteria: * Is or will be inaccessible for registry follow-up * Meets exclusion criteria required by local requirements * Current or planned participation in a drug or device study that would interfere with participation in this registry or confound the results of this registry in the opinion of the investigator

Locations (1)

UMASS Chan Medical School

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

Safety Endpoint

Incidence of device-related serious adverse events during the index procedure

Time frame: 30 days post-index procedure

Effectiveness Endpoint

Technical success of the LOBO Vascular Occlusion System defined as occlusion of the intended target(s) with the LOBO occluder, assessed by angiography

Time frame: During index procedure

Data from ClinicalTrials.gov

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