Status:
ACTIVE_NOT_RECRUITING
Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCT
Lead Sponsor:
Intuitive Surgical
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 s...
Detailed Description
This is a prospective, interventional, single-centre, dual-arm study which will be conducted in the Netherlands and will involve up to 131 patients undergoing a pulmonary nodule biopsy using the Ion E...
Eligibility Criteria
Inclusion
- 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
- 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 bullae(s) with a size of \>1 cm on pre-procedure CT scan located in close proximity to target nodule(s) and near the planned trajectory of the biopsy instruments.
- Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.
- Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
- Patient underwent a pneumonectomy.
- Any invasive concomitant procedure (outside of lymph node staging) 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.
- Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
- Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation.
- Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
- Patient is not willing to comply with post study procedure participation requirements.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06084208
Start Date
September 15 2023
End Date
March 31 2026
Last Update
September 5 2025
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Netherlands, 6500 HB