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A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)

31 de agosto de 2026 atualizado por: Intuitive Surgical

A Randomized Controlled Trial Evaluating Lung Nodules - COMparing Percutaneous CT-Guided Biopsy And Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)

The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (≤2 cm): CT-guided percutaneous lung nodule biopsy and shape-sensing robotic-assisted bronchoscopy with cone-beam CT (ssRAB with CBCT).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

CT-guided percutaneous biopsy and ssRAB with CBCT are two types of lung nodule biopsy procedures routinely used in clinical practice. The study is designed to evaluate the diagnostic efficacy and safety of ssRAB with CBCT compared with CT-guided percutaneous lung nodule biopsy in adults requiring diagnostic evaluation of a pulmonary nodule. The co-primary objectives are to assess non-inferiority of diagnostic efficacy and superiority of safety.

The primary endpoints are diagnostic efficacy and the rate of peri-procedural pneumothorax (with or without intervention) associated with the assigned biopsy approach.

Eligible participants will be randomized 1:1 to either ssRAB with CBCT or CT-guided percutaneous lung nodule biopsy. If the clinical team determines that the assigned procedure is not suitable, the participant will receive the most appropriate standard of care instead. Both biopsy procedures will be performed according to routine clinical practice, and no experimental devices or procedures will be used.

Participants will be followed for up to 12 months through medical record review and routine clinical follow-up. Patient-reported quality of life and, optionally, work status will be assessed using questionnaires at multiple time points. No research-specific assessments, burdensome tests, or advanced imaging outside of standard care will be performed. A chest X-ray will be required following the biopsy procedure, consistent with routine clinical practice.

Tipo de estudo

Intervencional

Inscrição (Estimado)

550

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Reino Unido
      • London, Reino Unido, NW1 2PG
        • Recrutamento
        • University College London Hospitals NHS Foundation
        • Contato:
          • Ricky Thakrar, MD
  • Suíça
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Suíça, 4031
        • Recrutamento
        • Basel University Hospital
        • Contato:
          • Juegen Hetzel, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Patient is aged 18 years or older at time of consent.
  2. Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent).
  3. Target pulmonary nodule ≤2 cm in largest diameter.
  4. Patient is willing and able to give written informed consent for clinical study participation.

Exclusion Criteria:

  1. Patient has previously undergone a biopsy procedure of the target nodule by any approach.
  2. Patient was previously randomized in this study but did not undergo biopsy.
  3. Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
  4. Patient is pregnant or breastfeeding as determined by standard site practices.
  5. Patient lacks the capacity to provide informed consent for themselves, or is a vulnerable patient whose ability to protect their own interests or to consent freely may be diminished, including but not limited to, patients who may be unduly influenced through dependency on the sponsor, the hospital, or the study doctor.
  6. Patient is not willing to comply with study participation requirements.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
Participants randomized to pulmonary nodule biopsy using shape-sensing robotic-assisted bronchoscopy with cone-beam CT.
Procedimento: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
A bronchoscopic lung nodule biopsy procedure performed using shape-sensing robotic-assisted bronchoscopy with cone-beam CT guidance as clinically indicated and according to standard clinical practice.
Outros nomes:
  • ssRAB
  • Ion endoluminal system
Comparador Ativo: CT-Guided Percutaneous Lung Nodule Biopsy
Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
Procedimento: CT-guided percutaneous lung nodule biopsy
A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
Outros nomes:
  • Transthoracic Needle Aspiration (TTNA)
  • Transthoracic Needle Biopsy (TTNB)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Diagnostic Efficacy of the Assigned Biopsy Procedure
Prazo: At the index procedure
Diagnostic efficacy will be calculated as the proportion of patients who receive their assigned treatment multiplied by diagnostic yield of their assigned treatment.
At the index procedure
Peri-Procedural Pneumothorax Rate
Prazo: From procedure to 7 days (or until subsequent intervention, whichever occurs first).
Rate of peri-procedural pneumothorax related to the assigned index biopsy procedure, including pneumothorax identified on routine post-procedure imaging and clinically relevant pneumothorax requiring intervention or escalation of care.
From procedure to 7 days (or until subsequent intervention, whichever occurs first).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Diagnostic Yield
Prazo: At the index procedure
Diagnostic yield of the index biopsy procedure, defined according to American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) guidance
At the index procedure
Sensitivity for Malignancy
Prazo: Through 1 year post-procedure
Sensitivity of the index biopsy procedure for the diagnosis of malignancy, based on final diagnosis established through 1-year follow-up
Through 1 year post-procedure
Negative Predictive Value
Prazo: Through 1 year post-procedure
Negative predictive value of the index biopsy procedure based on final diagnosis established through 1-year follow-up
Through 1 year post-procedure
Diagnostic accuracy
Prazo: Through 1 year post-procedure
Diagnostic accuracy of the index biopsy procedure based on final diagnosis established through 1-year follow-up.
Through 1 year post-procedure
Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing
Prazo: At the index procedure
Proportion of biopsy specimens considered adequate for molecular profiling and/or immunohistochemistry (IHC) testing.
At the index procedure
Procedure-Related Adverse Events
Prazo: Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
Incidence of procedure-related adverse events.
Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
Procedure-related serious adverse events.
Prazo: Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
Incidence of procedure-related serious adverse events.
Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
All-Cause Mortality
Prazo: Through study exit
Incidence of all-cause mortality among study participants.
Through study exit
Length of Stay for Procedure-Related Adverse Events
Prazo: From the date of hospitalization for a procedure-related adverse event until hospital discharge, for events occurring up to 30 days following the index procedure
Duration of hospitalization attributable to procedure-related adverse events
From the date of hospitalization for a procedure-related adverse event until hospital discharge, for events occurring up to 30 days following the index procedure

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Intuitive Surgical

Investigadores

  • Investigador principal: Ricky Thakrar, MD, University College London Hospitals
  • Investigador principal: Neal Navani, MD, University College London Hospitals

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de agosto de 2026

Conclusão Primária (Estimado)

30 de abril de 2028

Conclusão do estudo (Estimado)

30 de abril de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

30 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de agosto de 2026

Primeira postagem (Real)

12 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ISI-RCT-EU4-2025

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Sim

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 .

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