A Prospective Investigation to Assess the Diagnostic Yield of using a Robotic Navigational Bronchoscopy System with Adjunct Real-time Imaging
- Conditions
- lung nodule identified on a CT scan which requires a biopsy procedure.Patients with a moderate to high risk of lung cancer10029107
- Registration Number
- NL-OMON53579
- Lead Sponsor
- Intuitive Surgical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 131
1. Patient is aged 18 years or older at time of consent.
2. Patient is suitable for elective nodule biopsy via bronchoscopy under
general anesthesia per investigator's discretion.
3. Patient has a solid or semi-solid pulmonary nodule(s) of * 6 mm and * 3 cm
in largest dimension (based on pre-procedure CT scan)
4. 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.
5. 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.
6. Patient is willing and able to give written informed consent for
investigation participation.
7. Patient is not legally incapacitated or in legal/court ordered institution.
1. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy
under general anesthesia as determined by Investigator prior to procedure.
2. Patient with type 1 pure ground glass opacity target nodule(s) intended for
biopsy during study procedure.
3. 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.
4. Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.
5. Patient with ASA *4.
6. Patient underwent a pneumonectomy.
7. Any invasive concomitant procedure (outside of lymph node staging) not
related to the pulmonary nodule(s) or suspected disease state.
8. Female patient of child-bearing potential who is unable to take adequate
contraceptive precautions or is known to be pregnant, and/or breast feeding.
9. Patient has a documented medical history of uncorrectable coagulopathy,
bleeding, or platelet disorder.
10. Patient is taking antiplatelet or anticoagulant medications that cannot be
stopped per standard practice.
11. 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.
12. Investigator, in their professional opinion, has decided that it is in the
patient*s best interest to not participate in the Clinical Investigation.
13. Patient is not willing to comply with post study procedure participation
requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary performance endpoint:<br /><br>- Diagnostic yield of sample(s) obtained (post learning curve)<br /><br>- Sensitivity CUSUM analysis (learning curve)</p><br>
- Secondary Outcome Measures
Name Time Method