Cios Mobile 3D Spin for Robotic Bronchoscopy (NCT04740047) | Clinical Trial Compass
CompletedNot Applicable
Cios Mobile 3D Spin for Robotic Bronchoscopy
United States38 participantsStarted 2021-02-01
Plain-language summary
Evaluate the clinical utility and early performance of the Cios 3D Mobile Spin in conjunction with the Ion Endoluminal System, to visualize and facilitate the sampling of pulmonary nodules between 1-3 cm via the airway.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject age 18 years and older
* Subject is suitable for elective bronchoscopy
* Subject with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease
* Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤3.5 cm in largest dimension
* Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus)
* Subject is a candidate for CT-guided needle biopsy
* Subject is able to understand and adhere to study requirements
* Subject is able to understand and adhere to study requirements and able to provide informed consent
* Subject is not legally incapacitated or in legal/court ordered institution
* Subject has no dependency on the investigator or sponsor
Exclusion Criteria:
* Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure
* Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure
* Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment
* Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e. \> 30 breaths per minute) per physician assessment
* Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C)
* World Health Organization functional Class IV Pulmonary Hypertension or history of clinically significant mPAP
* Known or suspecte…