A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
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).
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Carine Van den Abeele
- Telefonnummer: +41 21 821 2000
- E-post: Encompass@intusurg.com
Studera Kontakt Backup
- Namn: Martha Bean
- Telefonnummer: +41 21 821 2000
- E-post: Encompass@intusurg.com
Studieorter
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Canton of Basel-City
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Basel, Canton of Basel-City, Schweiz, 4031
- Rekrytering
- Basel University Hospital
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Kontakt:
- Juegen Hetzel, MD
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London, Storbritannien, NW1 2PG
- Rekrytering
- University College London Hospitals NHS Foundation
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Kontakt:
- Ricky Thakrar, MD
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Heidelberg, Tyskland, 69126
- Rekrytering
- Thoraxklinik Heidelberg
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Kontakt:
- Felix Herth, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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. |
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.
Andra namn:
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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. |
A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Diagnostic Efficacy of the Assigned Biopsy Procedure
Tidsram: 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. |
At the index procedure
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Peri-Procedural Pneumothorax Rate
Tidsram: 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. |
From procedure to 7 days (or until subsequent intervention, whichever occurs first).
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Diagnostic Yield
Tidsram: 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 |
At the index procedure
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Sensitivity for Malignancy
Tidsram: 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 |
Through 1 year post-procedure
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Negative Predictive Value
Tidsram: 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 |
Through 1 year post-procedure
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Diagnostic accuracy
Tidsram: 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. |
Through 1 year post-procedure
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Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing
Tidsram: At the index procedure
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Proportion of biopsy specimens considered adequate for molecular profiling and/or immunohistochemistry (IHC) testing. |
At the index procedure
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Procedure-Related Adverse Events
Tidsram: 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. |
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.
Tidsram: 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 serious adverse events. |
Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
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All-Cause Mortality
Tidsram: Through study exit
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Incidence of all-cause mortality among study participants. |
Through study exit
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Length of Stay for Procedure-Related Adverse Events
Tidsram: 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 |
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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ricky Thakrar, MD, University College London Hospitals
- Huvudutredare: Neal Navani, MD, University College London Hospitals
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ISI-RCT-EU4-2025
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