NL-OMON56343招募中不适用
A Prospective Investigation to Assess the Diagnostic Yield of using a Robotic Navigational Bronchoscopy System with Adjunct Real-time Imaging - Diagnostic yield with Robotic Navigational Bronchoscopy System and CBCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 131
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 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 Clinical
- •Investigation participation.
- •7. Patient is not legally incapacitated or in a legal/court ordered
- •institution.
排除标准
- •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) 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.
研究者
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