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

31. august 2026 opdateret af: 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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

550

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, NW1 2PG
        • Rekruttering
        • University College London Hospitals NHS Foundation
        • Kontakt:
          • Ricky Thakrar, MD
  • Schweiz
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Schweiz, 4031
        • Rekruttering
        • Basel University Hospital
        • Kontakt:
          • Juegen Hetzel, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Procedure: 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.
Andre navne:
  • ssRAB
  • Ion endoluminal system
Aktiv komparator: CT-Guided Percutaneous Lung Nodule Biopsy
Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
Procedure: CT-guided percutaneous lung nodule biopsy
A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
Andre navne:
  • Transthoracic Needle Aspiration (TTNA)
  • Transthoracic Needle Biopsy (TTNB)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic Efficacy of the Assigned Biopsy Procedure
Tidsramme: 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
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic Yield
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: Through study exit
Incidence of all-cause mortality among study participants.
Through study exit
Length of Stay for Procedure-Related Adverse Events
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Intuitive Surgical

Efterforskere

  • Ledende efterforsker: Ricky Thakrar, MD, University College London Hospitals
  • Ledende efterforsker: Neal Navani, MD, University College London Hospitals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. august 2026

Primær færdiggørelse (Anslået)

30. april 2028

Studieafslutning (Anslået)

30. april 2029

Datoer for studieregistrering

Først indsendt

30. juli 2026

Først indsendt, der opfyldte QC-kriterier

10. august 2026

Først opslået (Faktiske)

12. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ISI-RCT-EU4-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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