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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06735976
The ClinicalTrials.gov registry entry for NCT06735976 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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