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

31 agosto 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

550

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Regno Unito
      • London, Regno Unito, NW1 2PG
        • Reclutamento
        • University College London Hospitals NHS Foundation
        • Contatto:
          • Ricky Thakrar, MD
  • Svizzera
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Svizzera, 4031
        • Reclutamento
        • Basel University Hospital
        • Contatto:
          • Juegen Hetzel, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: 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.
Altri nomi:
  • ssRAB
  • Ion endoluminal system
Comparatore attivo: CT-Guided Percutaneous Lung Nodule Biopsy
Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
Procedura: CT-guided percutaneous lung nodule biopsy
A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
Altri nomi:
  • Transthoracic Needle Aspiration (TTNA)
  • Transthoracic Needle Biopsy (TTNB)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic Efficacy of the Assigned Biopsy Procedure
Lasso di tempo: 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
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic Yield
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: Through study exit
Incidence of all-cause mortality among study participants.
Through study exit
Length of Stay for Procedure-Related Adverse Events
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Intuitive Surgical

Investigatori

  • Investigatore principale: Ricky Thakrar, MD, University College London Hospitals
  • Investigatore principale: Neal Navani, MD, University College London Hospitals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 agosto 2026

Completamento primario (Stimato)

30 aprile 2028

Completamento dello studio (Stimato)

30 aprile 2029

Date di iscrizione allo studio

Primo inviato

30 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 agosto 2026

Primo Inserito (Effettivo)

12 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ISI-RCT-EU4-2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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