A Prospective Investigation to Assess the Diagnostic Yield of Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Diagnostic yield of sample(s) obtained (post learning curve)
研究概览
简要总结
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. The learning curve of the procedure will be assessed and data on safety will also be collected.
详细描述
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 Endoluminal System in conjunction with 3D imaging. Outcomes in these patients will be compared to 91 propensity score matched Cone Beam CT- Navigational Bronchoscopy (CBCT-NB) controls obtained from the site's existing CBCT-NB database.
The objectives of the study are focused on evaluating the procedure learning curve and characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, rate of tool in nodule, sensitivity for malignancy and safety.
A learning curve analysis will be retrospectively performed to determine when both operators have reached competency with the Ion Endoluminal System. Criteria for passing the learning curve for measuring proficiency in the CUSUM will be diagnostic yield. Additional parameters like tool in lesion and procedure durations will also be monitored.
All subjects will be followed up at 1 week after the procedure. If an adverse event was observed, a 30-day post-procedure visit will also take place. If the biopsy did not provide a diagnosis or did not show cancer and was still under observation, then they will have further follow up at 6 months. Similarly, if the status is unchanged (non-malignant diagnosis) and the nodule is still under observation, a 13 months visit should be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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) ≥
- •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.
研究组 & 干预措施
Robotic Navigational Bronchoscopy
Patients undergoing biopsy with the Ion Endoluminal System
干预措施: Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging (Device)
结局指标
主要结局
Diagnostic yield of sample(s) obtained (post learning curve)
时间窗: Up to 13 months post procedure]
Diagnostic yield is the number of nodules in which the procedure was diagnostic (either malignant or non-malignant), relative to the total number of attempted navigation procedures
次要结局
- Rate of achieving biopsy tool position within the targeted nodule(s) as confirmed by CBCT 3D imaging or the combination of multi-angle augmented fluoroscopy with diagnostic rapid onsite pathology (in the absence of a confirmatory spin).(At time of the biopsy procedure (Day 0))
- Sensitivity for malignancy of sample(s) obtained(Up to 13 months post procedure)