Recruiting

LOBO™ Device

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06735976

Conditions

Pulmonary Arteriovenous Malformations

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

PAVM Embolization

PAVM Embolization with a LOBO™ device

Study Details

Brief 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

Pulmonary Arteriovenous Malformations

Study ID

NCT06735976

Start date

Dec 17, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 1 PAVM with a feeding artery ≥2 mm in diameter and a feeding artery amenable to the use of LOBO™ device (i.e. feeding artery length of ≥1 cm). Given the length of embolic devices including LOBO™, the proximal vessel length to the PAVM sac must be of sufficient size for embolization to be feasible. If patients have at least 1 PAVM where the feeding artery length is ≥1 cm, they are eligible for enrollment.
  • Patients with multiple PAVMs meeting eligibility criteria may be enrolled with the intent of embolizing multiple different PAVMs with the LOBO™ device in the same embolization session or in separate sessions.
  • Estimated Glomerular Filtration Rate >30 ml/min
  • Per standard of care (SOC), all pregnant women to be enrolled must be in their 2nd or 3rd trimesters

Exclusion Criteria:

  • Confounding bleeding disorders other than HHT
  • Life-threatening iodinated contrast allergy not amenable to prophylactic therapy with steroids
  • Underlying coagulopathy
  • Patients on anti-platelets or anti-coagulation medications

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: PAVM Embolization

This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.

Interventions

PAVM Embolization

This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device.

PAVM Embolization with a LOBO™ device

Participants will undergo PAVM embolization with the LOBO™ device per standard of care.

Primary outcome measure

  • Proportion of Technical Success [ Time Frame: At treatment until stasis is achieved. Approximately 1 - 2 hours. ]

Central Contacts and Locations

Central contacts

Markeela Lipscomb

919-843-3670markeela_lipscomb@med.unc.edu

Desma Jones

919-843-9463desma_jones@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Desma Jones

919-843-9463desma_jones@med.unc.edu

Markeela Lipscomb

(919) 843-3670markeela_lipscomb@med.unc.edu

Principal Investigator:

Nima Kokabi

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Embolization
  • Pulmonary Arteriovenous Malformations
  • PAVM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-02-17.