Okami Medical ALPHA Registry

May 20, 2026 updated by: Okami Medical, Inc.

Okami Medical Comprehensive Registry Platform

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Chan Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a clinical condition treated with LOBO Vascular Occlusion System

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Analysis Population 1
Patients treated for the control of peripheral arterial bleeding/hemorrhage.
Device: LOBO Vascular Occlusion System
LOBO Vascular Occlusion System
Analysis Population 2
Patients treated for pulmonary arteriovenous malformations.
Device: LOBO Vascular Occlusion System
LOBO Vascular Occlusion System
Analysis Population 3
Patients treated with the LOBO Vascular Occlusion System.
Device: LOBO Vascular Occlusion System
LOBO Vascular Occlusion System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoint
Time Frame: 30 days post-index procedure
Incidence of device-related serious adverse events during the index procedure
30 days post-index procedure
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
During index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okami Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-01 (St. Francis Hospital IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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