Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

31 augustus 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

550

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigd Koninkrijk
      • London, Verenigd Koninkrijk, NW1 2PG
        • Werving
        • University College London Hospitals NHS Foundation
        • Contact:
          • Ricky Thakrar, MD
  • Zwitserland
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Zwitserland, 4031
        • Werving
        • Basel University Hospital
        • Contact:
          • Juegen Hetzel, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Andere namen:
  • ssRAB
  • Ion endoluminal system
Actieve vergelijker: 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.
Andere namen:
  • Transthoracic Needle Aspiration (TTNA)
  • Transthoracic Needle Biopsy (TTNB)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic Efficacy of the Assigned Biopsy Procedure
Tijdsspanne: 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
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic Yield
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: Through study exit
Incidence of all-cause mortality among study participants.
Through study exit
Length of Stay for Procedure-Related Adverse Events
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Intuitive Surgical

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 augustus 2026

Primaire voltooiing (Geschat)

30 april 2028

Studie voltooiing (Geschat)

30 april 2029

Studieregistratiedata

Eerst ingediend

30 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 augustus 2026

Eerst geplaatst (Werkelijk)

12 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 september 2026

Laatste update ingediend die voldeed aan QC-criteria

31 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ISI-RCT-EU4-2025

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren