Management of Complex Airway Stenoses With Dedicated Tailored Stents Wrought by 3D Computer-assisted Conception
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change of percentage of procedures conducted without complications at 1 week , 3 months and 6 months
研究概览
简要总结
Management of complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception
Dedicated Airway Stents for Central Airway Stenoses
DASCAS
Toulouse University Hospital is the sponsor of this research.
This research will be conducted with the support of AnatomikModeling and ADERSPOT
- Background: Tracheobronchial stent are devices designed to manage central airway stenoses of various origins. Their shape and sizes are however not suitable for stenosis of complex anatomy.
- Purpose: The investigators propose to test the feasibility and safety of treating complex airway stenoses with dedicated tailored stents wrought by 3D computer-assisted conception
Abstract: Central airway obstruction is currently managed with non-personalized stents, which are usually efficient but lead to severe and potentially lethal complications in 10% of cases (stent migration, obstructive granuloma, perforation, hemoptysis). These stents seem particularly unsuited for anatomically complex stenosis.
Dedicated airway stents (wrought and tailored by 3D computer-assisted conception based on 3D chest CT-scan), by fitting perfectly tracheal or bronchial anatomy, should dramatically improve the tolerance and safety of such prostheses.
This first feasibility study, dedicated to patients suffering from anatomically complex stenosis will test the safety of treating patients with these new approach. It should lead to larger studies evaluating these new types of stents in larger indications.
After 3D computer-assisted modelization of airways, a virtual prosthesis and its shape are designed and the shape of the stent is wrought by 3D-machining by AnatomikModeling®. The stent is then build and sterilized by Sebbin® and inserted during rigid bronchoscopy on the same terms as pre-existing models.
Close follow up is then conducted, including clinical evaluation after one week, three and six months; spirometry at one week and 6 months and chest CT-scan at one week.
详细描述
Study design: Prospective monocentric feasibility study
Arm number or label and arm type: Only one experimental arm
Interventions:
After signature of a informed consent
Collection of clinical data (age, sex, etiology, site and mechanism of the stenosis, previous treatments dyspnea, quality of life (VQ11 questionnaire))
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
- 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
- •Signature of the informed consent form
- •Patient with a complex upper airway stenosis .
- •Symptomatic stenosis ( Dyspnea > NYHA II , cough, PEF < 50%)
- •Stenosis whose complex anatomy does not allow the establishment of a currently available stent on the market: the assessment of the experts ( consensus decision between 3 bronchoscopistes of interventional endoscopy service) or after failure of one or several models.
- •Affiliated with a social security scheme
排除标准
- •Indication of implementation of emergency aid : signs of acute respiratory distress , PEF < 20 % predicted , SpO2 oxygen saturation <90 % on room air
- •Contraindication to rigid bronchoscopy (severe coagulation disorders not correct )
- •Patient under legal protection system
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
new 3D device
dedicated tailored stents wrought by 3D computer-assisted conception
干预措施: new 3D device (Device)
结局指标
主要结局
Change of percentage of procedures conducted without complications at 1 week , 3 months and 6 months
时间窗: Change of percentage of procedures conducted without complications at 1 week, 3 months and 6 months
percentages of procedures conducted without complication at 1 week, 3 months and 6 month and their confidence interval at 95% and incidences at 1 week, 3 months and 6 months for each complication will be calculated.
次要结局
未报告次要终点