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The LungVision Navigational Platform for Preoperative Labeling of Pulmonary Ground Glass Nodules With Fiducial Markers

NCT07180823 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-09-18

No results posted yet for this study

Summary

Based on current evidence, there are no studies investigating the possibility of placing a fiducial marker using augmented fluoroscopy, particularly for partially solid lesions that are often not visible on traditional fluoroscopy. The study in question could provide evidence that will allow, in the future, the use of the LungVision system and radial ultrasound to effectively mark a lesion with a ground glass component highly suspected of malignancy via bronchoscopy, avoiding more invasive marking procedures such as trans-thoracic marking. Correct marking of the target lesion will allow easy identification of the lesion during surgery and its complete removal through small resections, obtaining a definitive histological diagnosis and, in some cases, radical oncological treatment with preservation of healthy lung tissue.

Conditions

Interventions

DEVICE

Bronchoscopy with Lung Vision navigation system

The procedure begins with inspection of the airways up to the subsegmental branches using a flexible bronchoscope. During the procedure, augmented fluoroscopy will be used as a guidance tool, which is already in use at our operating unit as part of normal clinical practice, and will be combined with radial ultrasound using a mini probe. Once the peripheral lesion has been located, a cytological and histological sample will be taken using a needle and/or forceps and/or cryoprobe under augmented fluoroscopic guidance and with R-EBUS, as per normal current clinical practice. If atypical cells or malignant tumour cells are found during the extemporaneous cytological examination, the FM, acquired specifically for the study, will be positioned to mark the pulmonary nodule. A coil-tailed FM will be used. Enhanced fluoroscopy will be used via the LungVision system.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Piero Candoli, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-21
Primary Completion
2026-01-01
Completion
2026-02-28

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07180823 on ClinicalTrials.gov