Menu
Enrolling by invitation NCT07525518

Okami Medical ALPHA Registry

— Observational Arterial Bleed Pulmonary Arteriovenous Malformation Embolization Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LOBO Vascular Occlusion System.
Who it may be relevant to
Registry conditions: Arterial Bleed, Pulmonary Arteriovenous Malformation, Embolization, Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Okami Medical Comprehensive Registry Platform

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.

Interventions

  • Device LOBO Vascular Occlusion System
    LOBO Vascular Occlusion System

Primary outcome measures

  • Safety Endpoint [Time frame: 30 days post-index procedure]
  • Effectiveness Endpoint [Time frame: During index procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • University of Colorado — Aurora
  • UMASS Chan Medical School — Worcester
  • University of North Carolina at Chapel Hill — Chapel Hill
  • Charlotte Radiology — Charlotte

Identifiers

NCT: NCT07525518 · 25-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗