The LUCENT Study - LUng Lesion Assessment Via BF-UCP190F for Central and Extended Nodal Targeting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Ability to visualize and sample a priori defined lesion in the inner or middle third of the lung with BF-UCP190F.
研究概览
简要总结
The Olympus BF-UCP190F bronchoscope combines the reach of a thinner bronchoscope with the benefit of real-time ultrasound, enabling direct lesion visualization and sampling deeper into the lung. Following promising first-in-human data, the LUCENT study aims to evaluate the utility feasibility, effectiveness and safety of this device in a multicenter setting, generating real-world evidence to inform broader adoption in global markets.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Willing and able to provide informed consent.
- •≥18 years of age.
- •The target lesion(s) must be located within the inner and middle two-thirds of the lung, as determined prospectively using the Software-Assisted Method (SAM). To ensure accurate localization, SAM applies anatomical measurements to classify lesions as inner, middle, or outer third of the lung. The lesion must contact the border of the inner two-thirds region; lesions fully outside this region will be excluded from the study cohort. In addition, the lesion must be located at least two airway generations distal to the main carina, as confirmed radiographically by the bronchoscopist
- •Target lesion: nodule ≥ 10mm or lymph node ≥ 5mm.
- •Target lesion location documented on CT or PET report.
- •Indicated for bronchoscopy.
- •Bronchoscopic procedure scheduled within 30 days of the CT or PET report.
- •Patient qualifies for a procedure using the BF-UCP190F bronchoscope and the ViziShot 2 25 needle based upon the approved indications for use for those devices.
排除标准
- •Concurrently participating in another competing clinical study.
- •Unwilling or unable to return for follow-up, e.g., plans for relocation, unsuitable transportation.
- •Patient not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
- •Currently on anticoagulation that cannot be paused, or a coagulation disorder that, in the opinion of the investigator, would pose an increased risk of bleeding.
- •Intraprocedural identification of intrinsic and endoscopically visualized endobronchial lesion for which adequate biopsy can be obtained via endobronchial biopsy.
结局指标
主要结局
Ability to visualize and sample a priori defined lesion in the inner or middle third of the lung with BF-UCP190F.
时间窗: Index Procedure
The primary endpoint-the proportion of a priori defined inner/middle-third lesions visualized and sampled using the BF-UCP190F-will be summarized using descriptive statistics, including frequency and percentage with 95% confidence intervals.
次要结局
未报告次要终点