InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy.
研究概览
简要总结
The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses.
详细描述
Participants in this study require a lung biopsy to confirm if they have a lung tumour. A biopsy is a procedure where a piece of lung tissue is removed for testing. Current biopsy techniques cannot guarantee the exact location of lung tumours, so biopsies can be taken from healthy tissue.
The BioSpy System (BSS) is a device with a probe, which is placed inside a normal biopsy needle. The tip of the probe contains sensors, that will scan the composition of the tissue which is in contact with the sensors.
The INSPECT study aims at collecting the sensor data, with the goal of being able to differentiate the different tissues.
All study participants will have a biopsy with the BSS. Participants will have a hospital visit for the procedure, and will have to stay up to 16 hours after their procedure as per normal hospital practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking
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
- •Age > 18 years
- •Subjects with lesions eligible for lung biopsy under general anesthesia.
- •Lesion localization:
- •Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or
- •Peripheral lesions ≥ 20 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or ultrasound analysis (RP EBUS with central localization of the ultrasound probe) during the procedure.
- •Written Informed Consent to participate in the study.
排除标准
- •Target lesion <10 mm for central and <20 mm for peripheral lesions (as determined on previous imaging)
- •Contra-indication to bronchoscopy procedures
- •Contra-indication to general anesthesia
- •Any subject that is, according to the discretion of the investigator, not eligible for study participation
- •Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
研究组 & 干预措施
All patients will be allocated to the same study arm.
During the bronchoscopic biopsy procedure, the study device will be entered through the bronchoscope to the level of the lesion. At lesion level, the BioSpy System sensor will make several measurements of the tumors and peripheral lung nodules and masses.
干预措施: BioSpy System (Device)
结局指标
主要结局
The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy.
时间窗: During the bronchoscopy procedure, up to 79 minutes
The primary endpoint was defined as the proportion of patients in which at least one non-anomalous biophysical measurement was obtained by the BSS in the lesion. This endpoint represents the procedural success rate being defined as the BioSpy System obtaining at least one non-anomalous impedance measurement in the lesion during the procedure, divided by the total number of patients in whom BSS was used.
次要结局
- The Ability of BioSpy System to Differentiate the Lesion From Healthy Tissue(During the bronchoscopy procedure, up to 79 minutes)
- The Ability of BioSpy System to Differentiate Various Lesion Types(During the bronchoscopy procedure, up to 79 minutes)