Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
Résumé de l'étude
The purpose of this study is to collect data to understand how accurately medical professionals utilize the Ion Endoluminal System, imaging (e.g., CT scan), and other medical skills during a bronchoscopic lung biopsy or localization procedure. The Ion Endoluminal System has been approved for use in bronchoscopy in the European Union, the United Kingdom, and Switzerland since 2023. It is a robotic bronchoscopy system. The data will help to understand standard practices in different regions of Europe. It will also show the diagnostic and therapeutic pathway of patients with a lung nodule after treatment with the Ion Endoluminal System. Up to 1200 individuals will be included in this study across approximately 12 different participating hospitals in Europe. All data collected in this study will be routinely collected by your clinic, and no examinations will be conducted specifically for the purposes of this study. Depending on your procedure (lung biopsy or localization procedure) and the outcome of the tissue sample (cancer or no cancer), the study will last either 12 or 24 months.
(BASEC)
Intervention étudiée
The Ion Endoluminal System has been approved for use in bronchoscopy in the European Union, the United Kingdom, and Switzerland since 2023. It is a robotic bronchoscopy system consisting of a thin plastic tube known as a catheter. The catheter has a sensor that indicates its position in the lung and guides the physician during the procedure. The robotic arm allows your physician to maneuver the catheter within your airways and stabilize the catheter during the procedure. The system does not perform any movement or activity without input and control from your physician.
Once the targeted nodule is reached, your physician will take a tissue sample for analysis using instruments (e.g., needle or forceps). If you undergo a localization procedure, your physician will place a marker through the catheter near the nodule.
No part of this study involves an experimental device or procedure. The Ion Endoluminal System is routinely used by your physician for this procedure.
(BASEC)
Maladie en cours d'investigation
Lung Nodule
(BASEC)
1. The patient is 18 years of age or older at the time of consent. 2. The patient is planned for a biopsy of a lung lesion and/or a localization procedure using the Ion Endoluminal System. 3. The patient is willing and able to provide written informed consent to participate in the clinical study. (BASEC)
Critères d'exclusion
1. The patient is participating in an interventional research study or a research study involving investigational products with unknown safety profiles that would affect participation in this study or study outcomes. 2. Female patient who is pregnant or breastfeeding; determined by the standard practice of the study center. 3. The patient is legally incompetent or is, by court order, in an institution or belongs to a known vulnerable population, including but not limited to dependence on the sponsor, hospital, or investigator. 4. The patient is not willing to meet the participation conditions following the study procedure. 5. The investigator has determined in their professional opinion that it is in the best interest of the patient not to participate in the study. (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Intuitive Surgical Sàrl
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med. Thomas Gaisl, PhD
+41 43 253 17 32
thomas.gaisl@clutterusz.chUniversitätsspital Zürich, Klinik für Pneumologie Rämistrasse 100, 8091 Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
19.08.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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