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临床试验/NCT04722432
NCT04722432已完成不适用

Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
1
主要终点
accuracy of the deployment method

研究概览

简要总结

A novel OTS detachable probe system carried outside and along the flexible bronchoscope has been developed. Using this novel system, the operator can deploy the probe in the target bronchus and lesion and completely detach the scope from the probe.

详细描述

Lung ablative therapies have growing interest in the treatment of early-stage primary lung cancer in surgical high-risk patients and as part of multimodal treatment in patients with large lesions or metastatic malignant disease in the lungs. Endobronchial ablative strategies allow deliver y of these therapies through a natural orifice and minimally invasive approach, potentially improving safety and reducing related morbidity. Application and deployment of this system allows the operator to have constant control of the airway, preventing life-threatening hemoptysis and other complications. We hypothesize that this novel detachable OTS system can be successfully deployed in the peripheral parenchymal target with potential clinical applications in the near future.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who follow surgery for the removal of diseased lungs before being submitted to a bilateral lung transplant.

排除标准

  • 未提供

结局指标

主要结局

accuracy of the deployment method

时间窗: Time of procedure

will be measured by bidimensional fluoroscopy images (antero-posterior and latero-lateral). The deployment will be considered successful if the tip of the probe is positioned at a distance less than 5 mm in both axes from the target model and stay stable in place over 5 minutes of ventilation.

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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