Actively Recruiting
Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations
Led by University of North Carolina, Chapel Hill · Updated on 2026-02-17
30
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
O
Okami Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate both the technical success and efficacy of using the LOBO™ device in patients undergoing embolization of Pulmonary Arteriovenous Malformations (PAVM). The main question\[s\] it aims to answer \[is/are\]: * What is the technical success rate, the number of LOBO™ devices needed for occlusion, and time to occlusion for each feeding artery during PAVM embolization using the LOBO™ device? * What is the short-term occlusion rate of the LOBO™ device for PAVM embolization (6 months post-embolization)? * What are the medium- and long-term occlusion rate of the LOBO™ device in PAVMs (12 months and 36 months post embolization)? Researchers will compare the percentage of LOBO™ embolized PAVMs that develop recanalization at 6, 12, and 36- month intervals compared to percentage of conventionally embolized PAVMs that develop recanalization at the same intervals. Participants will undergo the embolization procedure and be followed for 36 months after the procedure. There will be a total of 4 study visits: * Treatment visit * 6-Month Follow-up visit * 12-Month Follow-up visit * 36-Month Follow-up visit At each clinical follow-up visit participants will undergo imaging with a computed tomography angiography (CTA) of the chest.
CONDITIONS
Official Title
Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 1 pulmonary arteriovenous malformation with a feeding artery 2 mm or larger in diameter and a feeding artery length of at least 1 cm suitable for LOBO12 device use
- Patients with multiple eligible PAVMs may have multiple embolizations in one or separate sessions
- Estimated glomerular filtration rate greater than 30 ml/min
- Pregnant women must be in their 2nd or 3rd trimester to enroll
You will not qualify if you...
- Bleeding disorders other than hereditary hemorrhagic telangiectasia
- Life-threatening allergy to iodinated contrast not manageable with steroids
- Underlying blood clotting disorders
- Use of anti-platelet or anti-coagulation medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
M
Markeela Lipscomb
CONTACT
D
Desma Jones
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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