Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Zürich
(BASEC)
Sponsor
Intuitive Surgical Sàrl
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Thomas Gaisl, PhD
+41 43 253 17 32
thomas.gaisl@clutterusz.chUniversitätsspital Zürich, Klinik für Pneumologie Rämistrasse 100, 8091 Zürich
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
19.08.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System (BASEC)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Registrierungsdatum
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Einschluss des ersten Teilnehmers
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Sekundäre Sponsoren
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Weitere Kontakte
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Sekundäre IDs
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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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Weitere Informationen zur Studie
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Ergebnisse der Studie
Zusammenfassung der Ergebnisse
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Link zu den Ergebnissen im Primärregister
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