Arterial BleedNCT07525518
Okami Medical ALPHA Registry
An observational study of Arterial Bleed and Pulmonary Arteriovenous Malformation, run by Okami Medical, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Bleed, Pulmonary Arteriovenous Malformation, Embolization
- What is being tested?
- LOBO Vascular Occlusion System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Mar 2026to Aug 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a clinical condition treated with LOBO Vascular Occlusion System
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
University of Colorado
Aurora, Colorado, 80045
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Charlotte Radiology
Charlotte, North Carolina, 28202
UMASS Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: 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.
- Being tested
- LOBO Vascular Occlusion System
- Medical subject headings
- Pulmonary Arteriovenous Fistulas, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOBO Vascular Occlusion SystemDevice
LOBO Vascular Occlusion System
| Study group | Role | What they receive |
|---|---|---|
| Analysis Population 1 | Patients treated for the control of peripheral arterial bleeding/hemorrhage. Receives: Device: LOBO Vascular Occlusion System | |
| Analysis Population 2 | Patients treated for pulmonary arteriovenous malformations. Receives: Device: LOBO Vascular Occlusion System | |
| Analysis Population 3 | Patients treated with the LOBO Vascular Occlusion System. Receives: Device: LOBO Vascular Occlusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
Incidence of device-related serious adverse events during the index procedure
Measured: 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
Measured: During index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Mar 2026
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial BleedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Okami Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525518
- Sponsor's protocol ID
- 25-01
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Okami Medical Comprehensive Registry Platform
- ClinicalTrials.gov ID
- NCT07525518
- Acronym / sponsor ID
- 25-01
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Okami Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Analysis Population 1 | – | Device: LOBO Vascular Occlusion SystemPatients treated for the control of peripheral arterial bleeding/hemorrhage. |
| Analysis Population 2 | – | Device: LOBO Vascular Occlusion SystemPatients treated for pulmonary arteriovenous malformations. |
| Analysis Population 3 | – | Device: LOBO Vascular Occlusion SystemPatients treated with the LOBO Vascular Occlusion System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical condition treated with LOBO Vascular Occlusion System
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOBO Vascular Occlusion SystemLOBO Vascular Occlusion System | Device | Analysis Population 1, Analysis Population 2, Analysis Population 3 |
Primary outcome
Safety Endpoint
Time frame: 30 days post-index procedure
Incidence of device-related serious adverse events during the 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Bleed and Pulmonary Arteriovenous Malformation, run by Okami Medical, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint (time frame: 30 days post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.