NCT07525518

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Mar 2026Aug 2030

Study Start

First participant enrolled

March 31, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Arterial BleedPulmonary Arteriovenous MalformationEmbolizationHemorrhage

Outcome Measures

Primary Outcomes (2)

  • Safety Endpoint

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

    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

    During index procedure

Study Arms (3)

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

LOBO Vascular Occlusion SystemDEVICE

LOBO Vascular Occlusion System

Analysis Population 1Analysis Population 2Analysis Population 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a clinical condition treated with LOBO Vascular Occlusion System

You may qualify if:

  • 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

You may not qualify if:

  • Is or will be inaccessible for registry follow-up
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMASS Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Pulmonary Arteriovenous FistulasHemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)