- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07682012
LungVision AI-Augmented Fluoroscopic Navigation for Intraoperative Pulmonary Nodule Localization
Clinical Feasibility, Localization Accuracy, and Safety of the LungVision System for Intraoperative Localization of Small Pulmonary Nodules During Thoracoscopic Surgery: A Prospective Single-Center Pilot Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Lung cancer is the leading cause of cancer-related mortality worldwide, and accurate intraoperative localization of small pulmonary nodules is critical for guiding thoracoscopic resection. Conventional localization methods, including CT-guided percutaneous dye injection and virtual bronchoscopic navigation, carry limitations such as radiation exposure, pneumothorax risk, and dependence on pre-procedural planning without real-time intraoperative feedback.
The LungVision system (Body Vision Medical, Israel) is an AI-augmented fluoroscopic bronchoscopic navigation platform that integrates preoperative CT imaging with real-time C-arm fluoroscopy via machine learning-based image fusion. The system provides continuous intraoperative tool-tip tracking and lesion overlay without additional radiation beyond standard fluoroscopy, enabling real-time navigational feedback during bronchoscopic procedures.
This prospective, single-center, single-arm pilot study was conducted at the Department of Thoracic Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. A total of 14 patients with small pulmonary nodules requiring preoperative localization prior to video-assisted thoracoscopic surgery (VATS) were enrolled between January and December 2024. Each patient underwent dual localization: preoperative marking via CT-guided percutaneous dye injection or virtual bronchoscopic navigation (Broncus Archimedes Software System), followed by intraoperative localization using the LungVision system with ICG dye injection under fluoroscopic guidance.
The primary outcome was localization success rate, defined as the proportion of patients achieving fluoroscopic tool-in-lesion confirmation using the LungVision system. Secondary outcomes included complete resection rate (confirmed by pathological examination), navigation time, total operative time, and perioperative complication rate assessed up to 30 days postoperatively. Thoracoscopic resection was performed based on the combined localization findings, and all resected specimens were submitted for histopathological analysis.
This study was approved by the Institutional Review Board of Tri-Service General Hospital (IRB No.: A202303004) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrollment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Taiwan
-
Taipei, Taiwan, Taiwan, 114202
- Tri-Service General Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 18-65 years
- Scheduled to undergo thoracoscopic resection for solitary, subsolid, or ground-glass pulmonary nodules requiring localization
- Lesion characteristics and CT imaging indicating need for preoperative localization, as determined by the attending surgeon
- Able and willing to complete the study protocol
- Able to provide written informed consent
Exclusion Criteria:
- Age >65 years
- Pregnancy
- Bleeding tendency or current use of anticoagulants
- Impaired consciousness or inability to communicate
- Cognitive impairment precluding autonomous consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: LungVision AI-Augmented Fluoroscopic Navigation
Patients underwent intraoperative pulmonary nodule localization using the LungVision system (Body Vision Medical, Israel), an AI-augmented fluoroscopic bronchoscopic navigation platform that integrates preoperative CT imaging with real-time C-arm fluoroscopy via machine learning-based image fusion.
Under bronchoscopic guidance, the navigational tool was advanced toward the target lesion, and tool-in-lesion confirmation was verified under fluoroscopic overlay.
Upon successful localization, indocyanine green (ICG) dye was injected transbronchially to mark the target nodule.
All patients additionally received preoperative localization via CT-guided percutaneous dye injection or virtual bronchoscopic navigation (Broncus Archimedes Software System) as part of the dual-localization protocol.
Subsequent video-assisted thoracoscopic surgery (VATS) was performed based on the combined localization findings.
|
The LungVision system is an AI-augmented fluoroscopic bronchoscopic navigation platform developed by Body Vision Medical (Israel).
The system integrates preoperative CT imaging with real-time intraoperative C-arm fluoroscopy using machine learning-based image fusion to provide continuous tool-tip tracking and lesion overlay.
The system guides the bronchoscopic navigational tool to the target pulmonary nodule without additional radiation beyond standard fluoroscopy.
Upon tool-in-lesion confirmation, indocyanine green (ICG) dye is injected transbronchially for surgical marking prior to thoracoscopic resection.
As part of the dual-localization protocol, all patients received preoperative localization via one of the following methods prior to LungVision intraoperative navigation: (1) CT-guided percutaneous dye injection using methylene blue, or (2) virtual bronchoscopic navigation using the Broncus Archimedes Software System.
The choice of preoperative localization method was determined by the operating surgeon based on nodule characteristics and clinical judgment.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Localization Success Rate
Prazo: Intraoperative
|
Proportion of patients in whom successful intraoperative pulmonary nodule localization was achieved using the LungVision system, defined as fluoroscopic tool-in-lesion confirmation verified by the operating surgeon based on real-time AI-augmented fluoroscopic overlay.
Localization was considered successful when the navigational tool tip was confirmed to be positioned within or immediately adjacent to the target nodule under fluoroscopic guidance prior to dye injection.
|
Intraoperative
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TSGH-LV-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Carcinoma pulmonar de células não pequenas
-
Taichung Veterans General HospitalConcluídoCardiotoxicidade | Carcinoma de Pulmão de Células não Pequenas (Termo MeSH: Carcinoma, Non-Small-Cell Lung) | Efeitos Secundários e Reações Adversas Relacionadas com Medicamentos (Termo MeSH) | Inibidor da Tirosina Quinase do EgfrTaiwan
-
Fondazione del Piemonte per l'OncologiaRecrutamentoCâncer de mama | Cancro do ovário | Câncer colorretal | Melanoma (câncer de pele) | Carcinoma de Pulmão de Células não Pequenas (Termo MeSH: Carcinoma, Non-Small-Cell Lung)Itália
-
Novartis PharmaceuticalsRescindidoMelanoma | Avançado EGFR mutante non Small Cell LungCancer (NSCLC) | KRAS G12-MUTANT NSCLC | Câncer de células escamosas esofágicas (SCC) | Cabeça/pescoço SCC | Tumores estromais gastrointestinais avançados (GIST) | NRAS/Braft WT avançado melanoma cutâneoEstados Unidos, Taiwan, Holanda, Canadá, Espanha, Cingapura, Itália, Japão, Coréia do Sul
Ensaios clínicos em LungVision System
-
Reciprocal LabsCalifornia HealthCare FoundationConcluído
-
Muş Alparlan UniversityRecrutamentoMarcha, EspásticaPeru
-
ContinUse Biometrics Ltd.Concluído
-
St. Joseph's Healthcare HamiltonRecrutamentoTranstorno neurocognitivo leveCanadá
-
Boston Scientific CorporationConcluídoDoenças pancreáticas | Doenças das vias biliares | Doença HepáticaEstados Unidos, Índia, Hong Kong, China
-
SpineSave AGRecrutamentoEspondilartrite | Instabilidade Coluna Lombar | Espondilolistese Degenerativa | Estenose Espinhal Lombar Degenerativa | Discopatia | Artrose da Articulação FacetáriaSuíça
-
Neo Medical SAConfinisCPMAtivo, não recrutandoTrauma | Doença degenerativa do disco | Estenose espinal | Espondilolistese | Tumor Espinhal | Pseudoartrose da Coluna VertebralAlemanha, Espanha
-
ENTire Medical Ltd.Concluído
-
Medtronic MiniMed, Inc.Ainda não está recrutandoDiabetes tipo 1 (T1D)Espanha, França, Reino Unido, Itália, Alemanha, Holanda
-
ReVivo Medical, Corp.The Cleveland Clinic; Albany Medical College; IGEARecrutamentoDor de pescoço | Espondilose | Espondilose Com Mielopatia | Espondilose com Radiculopatia | Espondilose com Radiculopatia Região Cervical | Distúrbio do Disco Intervertebral CervicalEstados Unidos