Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System (NCT05867953) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System
United Kingdom200 participantsStarted 2023-04-20
Plain-language summary
The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans. Data on safety will also be collected.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is aged 18 years or older at time of consent.
✓. Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion.
✓. Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan).
✓. Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 (≥4) airway generations out (trachea = generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan.
✓. Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. High risk for malignancy patients are eligible if a biopsy is required or requested prior to intervention.
✓. Patient is willing and able to give written informed consent for Clinical Investigation participation.
✓. Patient is not legally incapacitated or in a legal/court ordered institution.
Exclusion criteria
✕. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
✕. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
✕. Presence of mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan.
What they're measuring
1
Tool in Nodule
Timeframe: At time of the biopsy procedure (Day 0)
✕. Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
✕. Patient underwent a pneumonectomy.
✕. Any invasive concomitant procedure not related to the pulmonary nodule(s) or suspected disease state.
✕. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
✕. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.