New registry to monitor safety of LOBO device in bleeding emergencies
NCT ID NCT07525518
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This registry will follow 500 adults who receive the LOBO Vascular Occlusion System, a device used to block blood vessels in cases of arterial bleeding or other conditions. The goal is to see how safe and effective the device is in everyday medical practice. Participants are enrolled after treatment, and the study will track device-related complications and how well the device stops bleeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LOBO Vascular Occlusion System (a device used to block blood vessels)
- What this could lead to
- If successful, this registry will provide real-world data on how well the LOBO device works and its safety, helping doctors make better treatment decisions.
- What could go wrong
- This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be limited by patient selection and lack of a comparison group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with a clinical condition treated with LOBO Vascular Occlusion System
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Charlotte Radiology
Charlotte, North Carolina, 28202, United States
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UMASS Chan Medical School
Worcester, Massachusetts, 01655, United States
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University of Colorado
Aurora, Colorado, 80045, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a VR headset turn nursing students into Bleeding-Control experts?
- Can a new dissolvable dressing stop surgical bleeding faster?