NCT07761351Recrutement en cours
A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
Résumé
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).
Critères d'inclusion
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.
Critères d'exclusion
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.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 4
- Type d'étude
- Interventionnelle
- Pays
- Suisse, Allemagne, Royaume-Uni
- Promoteur
- Intuitive Surgical(Industrie)
- N° de protocole
- ISI-RCT-EU4-2025
- Pathologies
- Lung Cancer (Diagnosis), Lung Nodule
- Interventions
- Procédure
Traitements évalués
- Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
- CT-guided percutaneous lung nodule biopsy
Lieux · 3
- Basel, SuisseBasel University HospitalRecrute dans ce centre
- Heidelberg, AllemagneThoraxklinik HeidelbergRecrute dans ce centre
- London, Royaume-UniUniversity College London Hospitals NHS FoundationRecrute dans ce centre
Au total, dans le monde, les 3 centres listés au registre recrutent.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 25 septembre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.