A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
31 de agosto de 2026 actualizado 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).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
550
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Carine Van den Abeele
- Número de teléfono: +41 21 821 2000
- Correo electrónico: Encompass@intusurg.com
Copia de seguridad de contactos de estudio
- Nombre: Martha Bean
- Número de teléfono: +41 21 821 2000
- Correo electrónico: Encompass@intusurg.com
Ubicaciones de estudio
-
-
-
London, Reino Unido, NW1 2PG
- Reclutamiento
- University College London Hospitals NHS Foundation
-
Contacto:
- Ricky Thakrar, MD
-
-
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Suiza, 4031
- Reclutamiento
- Basel University Hospital
-
Contacto:
- Juegen Hetzel, MD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patient is aged 18 years or older at time of consent.
- Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent).
- Target pulmonary nodule ≤2 cm in largest diameter.
- Patient is willing and able to give written informed consent for clinical study participation.
Exclusion Criteria:
- Patient has previously undergone a biopsy procedure of the target nodule by any approach.
- Patient was previously randomized in this study but did not undergo biopsy.
- 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.
- Patient is pregnant or breastfeeding as determined by standard site practices.
- 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.
- Patient is not willing to comply with study participation requirements.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
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.
Otros nombres:
|
|
Comparador activo: CT-Guided Percutaneous Lung Nodule Biopsy
Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
|
A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic Efficacy of the Assigned Biopsy Procedure
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic Yield
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: Through study exit
|
Incidence of all-cause mortality among study participants.
|
Through study exit
|
|
Length of Stay for Procedure-Related Adverse Events
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ricky Thakrar, MD, University College London Hospitals
- Investigador principal: Neal Navani, MD, University College London Hospitals
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de agosto de 2026
Finalización primaria (Estimado)
30 de abril de 2028
Finalización del estudio (Estimado)
30 de abril de 2029
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de agosto de 2026
Publicado por primera vez (Actual)
12 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ISI-RCT-EU4-2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .