Okami Medical ALPHA Registry

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Okami Medical, Inc.
Study ID
NCT07525518
Status
Enrolling By Invitation

Conditions

  • Arterial Bleed
  • Embolization
  • Hemorrhage
  • Pulmonary Arteriovenous Malformation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LOBO Vascular Occlusion System — DEVICE
    LOBO Vascular Occlusion System

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
May 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Analysis Population 1
    Patients treated for the control of peripheral arterial bleeding/hemorrhage.
  • Arm: Analysis Population 2
    Patients treated for pulmonary arteriovenous malformations.
  • Arm: Analysis Population 3
    Patients treated with the LOBO Vascular Occlusion System.

Primary Outcome Measure

Safety Endpoint [ Time Frame: 30 days post-index procedure ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-
UMASS Chan Medical SchoolWorcesterMassachusetts01655-

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