Small Feasibility Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Observe the outcomes associated with patient-specific airway implants.
研究概览
简要总结
The goal of the small feasibility trial is to establish a method, material, and patient-specific design that is superior to what is in use today. The first round of patients are well known to the physician investigator and are familiar with the problem that is being resolved. The end goal of the project is to create a new patient-specific design that will last longer, fit better, and cause less trauma to the airway and the patient.
详细描述
Subjects will be selected from physician investigator's clinical practice where patients have had failure of current stenting procedures to achieve an adequate clinical outcome. A routine CT scan of the chest is required on all individuals going through the procedure for stent placement (rigid bronchoscopy). The physician investigator will use this CT scan to measure and build a patient-specific stent or modify existing stents to fit the specific need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Understand and voluntarily sign an informed consent form.
- •Patients must be at least 18 years of age
- •Patients must be able to undergo routine non-contrast CT scans of the chest
- •Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
- •The patients must have at least an expected 6 month survival.
- •Patient must be able to maintain standard of care follow-up schedule and have access to standard of care medications and nebulizer machines and/or suction and oxygen as required for primary disease management.
- •Patient must be able to personally provide consent and be able to describe Dyspnea and QOL and other patient-reported outcomes (PROs) required by study design
- •Patient must require a stent that is within the design envelope of the patient-specific stents, as defined by COS
排除标准
- •Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
- •Chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (I.e. Plavix within one year of drug eluding cardiac stent (DES)or 6 weeks following bare metal coronary stent)
- •Unstable cardiac disease
- •Allergy to silicone
- •Stenting to manage vascular compression syndromes.
- •Multi-drug resistant bacterial or fungal chronic infections
- •Emergent/urgent clinically indicated stent.
- •Chronic/permanent mechanical ventilation.
研究组 & 干预措施
Patient-Specific Tracheobronchial Stent
Observe and document the ability of a patient-specific tracheobronchial stent to improve a patient's quality of life and symptoms associated with airway stenosis.
干预措施: Silicone Stent Airway Implant (Device)
结局指标
主要结局
Observe the outcomes associated with patient-specific airway implants.
时间窗: Up to 90 days following treatment
Measure Quality of Life Index through Baseline Dyspnea Index, a validated survey tool
次要结局
未报告次要终点