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NCT06735976 · ClinicalTrials.gov registry record · NA
Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations
A NA study of Pulmonary Arteriovenous Malformations, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06735976: Recruiting NA study of Pulmonary Arteriovenous Malformations, sponsored by University of North Carolina, Chapel Hill.
NCT06735976 is a NA study of Pulmonary Arteriovenous Malformations that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06735976, a NA study of Pulmonary Arteriovenous Malformations, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Technical success will be defined as the successful deployment of the LOBO™ device in the intended vessel and complete occlusion of the vessel. Successful deployment will be defined as 1) no technical malfunctions in the LOBO™ deployment system that leads to an inability to deploy the device and 2) deployment of the device into the intended vessel and not into surrounding vessels. Complete occlusion will be defined as complete cessation of blood flow through the embolized vessel based on intrapr
Conditions Studied
Interventions
- DEVICE PAVM Embolization
- DEVICE PAVM Embolization with a LOBO™ device
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-12-17 |
| Est. Completion | 2029-12 |
| Phase | NA |
What NCT06735976 shows while recruiting
NCT06735976 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Pulmonary Arteriovenous Malformations appearing as the primary indexed condition, and to 2 interventions - of which PAVM Embolization is the first listed.
NCT06735976 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06735976 about?
NCT06735976 is a clinical study titled "Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations". 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...
What is the current status of trial NCT06735976?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-12-17. Estimated completion is 2029-12.
What conditions does trial NCT06735976 study?
This clinical trial studies the following conditions: Pulmonary Arteriovenous Malformations.
What interventions are being tested in trial NCT06735976?
The interventions under investigation include: PAVM Embolization (DEVICE), PAVM Embolization with a LOBO™ device (DEVICE).
Who is sponsoring clinical trial NCT06735976?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06735976 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06735976's enrollment target sits among peer trials
30 1594th of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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