ClinicalTrials.gg
Enrolling by invitationNCT07525518Updated Oct 30, 2026

Okami Medical ALPHA Registry

An observational study in Arterial Bleed, Pulmonary Arteriovenous Malformation and Embolization, sponsored by Okami Medical, Inc.. Enrolling by invitation at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Okami Medical, Inc. · Observational

Updated Oct 30, 20262 sites addedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Arterial Bleed
  • Pulmonary Arteriovenous Malformation
  • Embolization
  • Hemorrhage

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03

In context

Hemorrhage

1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.

This study's planned enrollment of 500 is above the median of 215 across 397 observational studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Okami Medical, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a clinical condition treated with LOBO Vascular Occlusion System

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient or their legally authorized representative is willing and able to provide per local requirements
  • Has or will receive treatment with an eligible Okami Medical device
  • Age ≥ 18 years

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Analysis Population 1

    Patients treated for the control of peripheral arterial bleeding/hemorrhage.

    Device: LOBO Vascular Occlusion System

  • Analysis Population 2

    Patients treated for pulmonary arteriovenous malformations.

    Device: LOBO Vascular Occlusion System

  • Analysis Population 3

    Patients treated with the LOBO Vascular Occlusion System.

    Device: LOBO Vascular Occlusion System

Interventions

  • DeviceLOBO Vascular Occlusion System

    LOBO Vascular Occlusion System

06

What researchers measure

Primary outcomes

  1. Safety Endpoint

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

    Time frame: 30 days post-index procedure

  2. 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

07

Study locations

6 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added
Show 2 added (2 United States)
  • Stanford University · Stanford, United States
  • Sarasota Memorial Health Care System · Sarasota, United States
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    2 sites added
    Show 2 added (2 United States)
    • Stanford University · Stanford, United States
    • Sarasota Memorial Health Care System · Sarasota, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07525518
Lead sponsor
Okami Medical, Inc.
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
Mar 31, 2026
Primary completion
Aug 2030 (estimated)
Completion
Aug 2030 (estimated)
Last update
Oct 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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