A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
31. august 2026 oppdatert av: 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).
Studieoversikt
Status
Rekruttering
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
550
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Carine Van den Abeele
- Telefonnummer: +41 21 821 2000
- E-post: Encompass@intusurg.com
Studer Kontakt Backup
- Navn: Martha Bean
- Telefonnummer: +41 21 821 2000
- E-post: Encompass@intusurg.com
Studiesteder
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London, Storbritannia, NW1 2PG
- Rekruttering
- University College London Hospitals NHS Foundation
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Ta kontakt med:
- Ricky Thakrar, MD
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Canton of Basel-City
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Basel, Canton of Basel-City, Sveits, 4031
- Rekruttering
- Basel University Hospital
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Ta kontakt med:
- Juegen Hetzel, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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.
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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 navn:
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Aktiv komparator: CT-Guided Percutaneous Lung Nodule Biopsy
Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
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A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic Efficacy of the Assigned Biopsy Procedure
Tidsramme: At the index procedure
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Diagnostic efficacy will be calculated as the proportion of patients who receive their assigned treatment multiplied by diagnostic yield of their assigned treatment.
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At the index procedure
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Peri-Procedural Pneumothorax Rate
Tidsramme: From procedure to 7 days (or until subsequent intervention, whichever occurs first).
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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.
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From procedure to 7 days (or until subsequent intervention, whichever occurs first).
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic Yield
Tidsramme: At the index procedure
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Diagnostic yield of the index biopsy procedure, defined according to American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) guidance
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At the index procedure
|
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Sensitivity for Malignancy
Tidsramme: Through 1 year post-procedure
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Sensitivity of the index biopsy procedure for the diagnosis of malignancy, based on final diagnosis established through 1-year follow-up
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Through 1 year post-procedure
|
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Negative Predictive Value
Tidsramme: Through 1 year post-procedure
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Negative predictive value of the index biopsy procedure based on final diagnosis established through 1-year follow-up
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Through 1 year post-procedure
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Diagnostic accuracy
Tidsramme: Through 1 year post-procedure
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Diagnostic accuracy of the index biopsy procedure based on final diagnosis established through 1-year follow-up.
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Through 1 year post-procedure
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Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing
Tidsramme: At the index procedure
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Proportion of biopsy specimens considered adequate for molecular profiling and/or immunohistochemistry (IHC) testing.
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At the index procedure
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Procedure-Related Adverse Events
Tidsramme: Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
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Incidence of procedure-related adverse events.
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Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
|
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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.
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Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
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All-Cause Mortality
Tidsramme: Through study exit
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Incidence of all-cause mortality among study participants.
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Through study exit
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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
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Duration of hospitalization attributable to procedure-related adverse events
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ricky Thakrar, MD, University College London Hospitals
- Hovedetterforsker: Neal Navani, MD, University College London Hospitals
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
28. august 2026
Primær fullføring (Antatt)
30. april 2028
Studiet fullført (Antatt)
30. april 2029
Datoer for studieregistrering
Først innsendt
30. juli 2026
Først innsendt som oppfylte QC-kriteriene
10. august 2026
Først lagt ut (Faktiske)
12. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ISI-RCT-EU4-2025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
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