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临床试验/NCT04714268
NCT04714268Unknown不适用

Comparison of Aorto-iliac Endovascular Interventions With and Without the EndoNaut Workstation

Therenva1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
Therenva
入组人数
150
试验地点
1
主要终点
Irradiation parameters: measurement of air Kerma (mGy)

研究概览

简要总结

The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.

详细描述

Minimally invasive endovascular interventions are increasingly replacing conventional surgeries, and have become the therapeutic benchmark for a large number of pathologies thanks in particular to advances in image-guided therapy. Therenva offers a comprehensive and consistent lightweight navigation solution (EndoNaut®) for endovascular procedures. This navigation station makes it possible to secure and guide the interventional gesture by providing relevant information extracted during the preoperative phase. This information is rendered in augmented reality using artificial intelligence algorithms and digital simulation. This alternative solution to a hybrid room, but which offers equivalent functionality, is compatible with all operating rooms, regardless of the interventional environment. Benefits of imaging fusion remain to be assessed on a larger scale. The aim of this multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral or bilateral aorto-iliac or iliac aneurysm/stenosis
  • Suitable for endovascular repair
  • Major patients
  • Patients not opposed to their participation in the study

排除标准

  • Patients requiring conventional surgical revascularization.

结局指标

主要结局

Irradiation parameters: measurement of air Kerma (mGy)

时间窗: At enrollment

Parameter given by the X-ray imaging device

Irradiation parameters: dose-area quantification (mGy/m2)

时间窗: At enrollment

Parameter given by the X-ray imaging device

Irradiation parameters: evaluation of the Fluoroscopy duration (min)

时间窗: At enrollment

Parameter given by the X-ray imaging device

Volume of contrast product used during the routine care procedure (ml)

时间窗: At enrollment

Volume are reported in mL

次要结局

  • Procedure time (min)(At enrollment)

研究者

发起方
Therenva
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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