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OpenTrials
Enrolling by Invitation

NCT Number: NCT07525518

Okami Medical ALPHA Registry

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.

Enrolling by Invitation

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Key information

Conditions

Arterial Bleed Embolization Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Arteriovenous Fistulas Pulmonary Arteriovenous Malformation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

LOBO Vascular Occlusion System

Device

LOBO Vascular Occlusion System

Primary outcomes

  1. Safety Endpoint

    Time frame: 30 days post-index procedure

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

  2. Effectiveness Endpoint

    Time frame: During index procedure

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

Sponsors and collaborators

Lead sponsor

Okami Medical, Inc.

Industry

Registry information

Official study title

Okami Medical Comprehensive Registry Platform

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 13, 2026
Registry last updated
Jul 21, 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.

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