AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- System Usability Score (SUS)
研究概览
简要总结
The goal of this clinical trial is to assess the overall usability of the Philips
AirWaze investigational device in patients indicated for CBCT-guided navigation bronchoscopy procedure. The main questions it aims to answer are to assess the:
- overall usability of the device
- accuracy of the tool-in-lesion confirmation scan
Participants will undergo bronchoscopy with the new navigation device and additional confirmation scans. Follow-up visit at 7days will be performed.
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
- •Age 18 years or older at the time of informed consent.
- •ASA physical status between 1 and
- •Subject is willing and able to give written informed consent for clinical investigation participation prior to the procedure.
- •Subject has a pulmonary lesion with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.
- •Suitable for CBCT-guided endobronchial nodule biopsy under general anaesthesia.
- •Pre-procedural (PET-)CT scan is available prior to the CBCT-NB intervention.
排除标准
- •Aged 17 or younger at the time of informed consent.
- •ASA physical status is equal to and greater than
- •Not willing or not able to give informed consent.
- •Does not indicate diagnostic evaluation with navigation bronchoscopy.
- •Not suitable for CBCT-guided endobronchial nodule biopsy via navigation bronchoscopy under general anaesthesia.
- •There is no recent pre-procedural (PET-)CT scan available.
- •Known bleeding disorders.
- •Contra-indication for temporary interruption of the use of anticoagulant therapy, such as acenocoumarol, warfarin, therapeutic dose of low molecular weight heparins, clopidogrel, or analogues, NOACs).
- •Known allergy for lidocaine or other allergies interfering with the procedure.
- •Uncontrolled pulmonary hypertension.
- •Recent and/or uncontrolled cardiac disease.
- •Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any reason such that endobronchial access is considered unsafe).
- •Potentially confounding drug or device trial during the clinical study. Co-enrollment in concurrent trials may be allowed provided pre-approval is obtained from the Philips Clinical Study Manager.
- •All vulnerable subjects, such as immune-compromised subjects, subjects lacking the capacity to provide consent, patients in emergencies, pregnant or breastfeeding women, or any other subject who meets exclusion criteria, according to applicable national laws, if any.
- •Woman of childbearing potential who is known to be pregnant on admission.
- •Any condition that in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the subject in the study.
- •Subject is Philips employee or their family members residing with this Philips employee.
研究组 & 干预措施
AirWaze
AirWaze - easy and advanced tools for CBCT guided lung interventions
干预措施: AirWaze (Device)
结局指标
主要结局
System Usability Score (SUS)
时间窗: Pre-procedure and immediately after the procedure
System Usability Score (SUS) of AirWaze investigational device. An average SUS of greater than 70 will indicate a good usability design of the AirWaze Software solution. The SUS will be measured per operator every 4 procedures. The questionnaire consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Minimum total score is 0 and maximum, 100.
Accuracy of the tool-in-lesion confirmation scan assessed by questionnaire "CBCT-FS compared to CBCT".
时间窗: Immediately after the procedure
Accuracy of the tool-in-lesion confirmation scan compared to the conventional scan based on questionnaire about tool-in-lesion definitions and usefulness of the scans to guide to the lesion (questionnaire "CBCT-FS compared to CBCT"). Image based tool-in-lesion confirmation accuracy of 90% will indicate that the CBCT-FS is postulated to be sufficient for navigation bronchoscopy.
System Usability Scale (SUS)
时间窗: after procedure, up to 2 hours
System Usability Scale (SUS) of AirWaze investigational device. An average SUS of greater than 70 will indicate a good usability design of the AirWaze Software solution. The SUS will be measured per operator every 4 procedures. The questionnaire consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Minimum total score is 0 and maximum, 100.
Number of Participants With Accurate Tool-in-lesion Confirmation Scan (Ultra-low Dose CBCT Scan) Compared to the Conventional Tool-in-lesion Confirmation Scan (CBCT Scan)
时间窗: after procedure, up to 1 hour
Accuracy of the tool-in-lesion confirmation scan (ultra-low dose CBCT scan) is defined as the number of participants where ultra-low dose CBCT scans were adequate to define tool-in-lesion compared to conventional CBCT scans (gold-standard). The accuracy is defined as the sum of the number of tool-in-lesion scans in both the ultra-low dose CBCT and conventional CBCT scans (i.e. true positives), and the number of no tool-in-lesion confirmation in both the ultra-low dose CBCT and conventional CBCT scans (i.e. true negatives), divided by the total number of ultra-low dose CBCT and conventional CBCT scan pairs. Image based tool-in-lesion confirmation accuracy of 90% will indicate that the ultra-low dose CBCT scan is postulated to be sufficient for navigation bronchoscopy.
次要结局
未报告次要终点