Comparative Study of the PRAEVAorta Device in Patients With an Abdominal Aortic Aneurysm (AAA) : Percentage of Adequacy to the Gold Standard
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- AAA volume
研究概览
简要总结
Nurea wants to set-up a pivotal phase clinical study for its software PRAEVAorta, a decision-making support for diagnosis and follow-up of abdominal aorta aneurysm. This study is a comparative study. Its purpose is to demonstrate the adequacy of PRAEVAorta to the current Gold Standard in the care of patients with abdominal aortic aneurysm. The currently benchmark methods are the maximal diameter method (Hand-held measurement of maximum diameter on scan images) and the segmentation method for the aneurysm volume (manual segmentation of scan images, then calculation of the AAA volume by counting the pixels).
The hypothesis is that 90% of the segmented patients have a volume ratio and a diameter ration equal to or greater than 90%.
详细描述
Control and quality assurance will be applied in the investigation site. The monitor mandated by the sponsor Nurea will ensure the follow-up and the proper completion of the study, the collection of data in writing, their documentation, recording and report, in accordance with the procedures in place and in accordance with good clinical practice as well as the laws and regulations in force.
Quality control visits realised at regular intervals will be realised by the monitor. During those visits, the following elements could be demanded:
- Informed consent forms, information note
- Respect of the plan of the study and the procedures defined in it
- Quality of the data collected in the Case Report Form (CRF): accuracy, missing data, consistency of data with the "source" documents (medical file, appointment book, originals of laboratory results).
- Management of any products
- Security data All contacts made will give rise to a specific written report
Three type of visits (quality control) will be realised:
- The initiation visit (realised in person) will concern every person potentially involved in the investigation. This visit will be about presenting the plan, redefine inclusion objectives, recall everyone's responsibility and the regulation, as well as answering question.
- The monitoring visits will be realised by the monitor after the first inclusion to ensure the respect of the plan and the regulation, as well as the quality of the collected data. Those visits will be realised every 2weeks, but the frequency can vary regarding the complexity of the study, of the number and the pace of inclusions. Therefore, there will be at least one visit per month.
- The close-out visit will be realised after the last data have been collected. The purpose of this visit is to verify the quality of the collected data, to update the documents before archiving.
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
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
- •Male or female
- •Patient equal or over 18 years old
- •Patient who has given and signed is informed consent
- •Patient with a diagnosed aneurysm
- •Infra-renal AAA
- •or ≥5mm increase in 6 months
- •or Ruptured AAA
- •Patient with legal capacity to make its own decisions,
- •Patient available for set-up and proper implementation of follow-up visits throughout the duration of the registry
排除标准
- •Pregnant or planning on becoming pregnant
- •Advancing Alzheimer's disease or socially dependent patient
- •Patient on opposition to the use of their data for this research
- •Patient under the age of 18
- •Incapable adult
- •Patient under guardianship, curatorship, or safeguard of justice
结局指标
主要结局
AAA volume
时间窗: First week
Measured in cubic millimeter (mm3)
AAA maximum diameter
时间窗: First week
Measured in millimeter (mm)
次要结局
未报告次要终点