NCT06406452招募中不适用
A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- The proportion of subjects that survive to 6 months post-splinting
研究概览
简要总结
The purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children.
The airway splint is bioresorbable, meaning the child's body will absorb the splint over about five years.
详细描述
Other sites will be added to the registration as sites are on-boarded.
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
- 1 Week 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have clinically significant tracheobronchomalacia and:
- •be unable to wean off of mechanical ventilation, and/or
- •be currently dependent on a tracheostomy tube, and/or
- •meet current indications for a tracheostomy or another surgical intervention for TBM
- •Subjects must have a life expectancy of at least 2 years, exclusive of TBM
- •Subjects must have a parent or legal guardian capable of giving consent on behalf of the subject, and must be willing and able to complete the requirements of clinical trial follow-up
- •Subject must have a physician willing to provide follow-up clinical data, including a bronchoscopy at 2 years
- •Subjects must be greater than 1 week of age and less than 4 years of age. (Infant subjects born preterm, with low birth weight, or small for gestational age are eligible for trial enrollment if their comorbidities do not present a contraindication to surgical intervention for subjects TBM and airways are of a size that can appropriately be treated with the range of splint sizes offered in this clinical trial)
- •Patency-Based Pre-Operative Inclusion Criteria:
- •- Subjects must have tracheobronchomalacia in the trachea, left main bronchus, or right main bronchus a minimum patency of less than 50% in one of these regions
- •Screening: In order for a subject to be sent to a clinical trial site for evaluation for the clinical trial, a subject must have tracheobronchomalacia with evidence of less than 50% minimum patency based on a Computed Tomography Scan (CT), Magnetic resonance imaging (MRI), or bronchoscopic exam at referring institution confirmed by an imaging or operative note from the local physician.
- •At Enrollment: The subject must have tracheobronchomalacia with minimum patency of less than 50% in the trachea and/or left mainstem bronchus and/or right mainstem bronchus, based on expiration/inspiration CT performed at a clinical trial site performed during visit 1
- •Intra-Operative Inclusion Criteria:
- •- The surgeon can safely dissect out the malacic trachea or bronchus/bronchi in order to place the splint
- •Pre-Operative
排除标准
- •Subject has significant fixed anatomic tracheal stenosis
- •Subject has untreated complete tracheal rings
- •Subject has single-lung anatomy
- •Subject has single-ventricle cardiac anatomy
- •Subject has external compression due to active malignancy, active infection, or an undrained cyst
- •Subject has a non-bioresorbable airway stent. Recent removal of any stent will require verification of integrity of the airway wall
- •Subject has a contraindication to surgery other than airway compromise
- •Subject has a known hypersensitivity to polycaprolactone or hydroxyapatite, and/or a previous unusual reaction to bioresorbable sutures
- •Subject has a genetic defect of cartilage formation
- •Subject has significant bronchomalacia distal to the mainstem as the predominant source of subject's airway obstruction
- •Membranous posterior wall intrusion is the predominant form of collapse
结局指标
主要结局
The proportion of subjects that survive to 6 months post-splinting
时间窗: 6 months post splint implantation
All-cause mortality within 6 months (180 days) of splint implantation will count against this endpoint.
The Proportion of splinted regions with equal or greater than (≥) 50% average patency at approximately 4 weeks visit (window ±2 weeks) after splint implantation
时间窗: Approximately 4 weeks (±2 weeks) post splint implantation
This will be measured by inspiratory/expiratory cat scan (CT), where average patency is defined as: average cross-sectional area in splinted region on expiration divided by average cross-sectional area in splinted region on inspiration.
次要结局
- The proportion of splinted regions with ≥50% minimum patency approximately 4 weeks visit (window ±2 weeks) post splint implantation as measured by video bronchoscopy(Approximately 4 weeks (±2 weeks) post splint implantation)
- Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 2 year visit(pre-op (prior to splint implementation), up to 2 year visit post splint implantation)
- Pediatric Quality of Life (PedsQL) Family Impact Module 6-months post-op(6-months post splint implantation)
- The proportion of splinted regions with an absolute increase in average patency of ≥20% from pre-op to approximately 4 weeks visit (window ±2 weeks) post splint implantation(Approximately 4 weeks (±2 weeks) post splint implantation)
- Pediatric Quality of Life (PedsQL) Family Impact Module pre-op(Pre-op (prior to splint implementation))
- The proportion of splinted regions with ≥50% minimum patency 2 years (window ± 4 months) post splint implantation(Approximately 2 years (window ± 4 months) post splint implantation)
- Pediatric Quality of Life Inventory Infant Scales (PedsQL) Pre-operative (pre-op) - up to 1 year visit(Pre-op (prior to splint implementation), up to 1 year visit post splint implantation)
- Pediatric Quality of Life Inventory Infant Scales (PedsQL) generic core scale post-op 2 year - up to 5 year visit(2 year, up to 5 year visit post splint implantation)
- Pediatric Quality of Life (PedsQL) Family Impact Module 2 years post-op(2 years post splint implantation)
- Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 4 year visit(pre-op (prior to splint implementation), up to 4 year visit post splint implantation)
- Pediatric Quality of Life (PedsQL) Family Impact Module 3 months post-op(3 months post splint implantation)
- Pediatric Quality of Life (PedsQL) Family Impact Module 4 years post-op(4 years post splint implantation)
- Pediatric Quality of Life (PedsQL) Family Impact Module 5 years post-op(5 years post splint implantation)
- Pediatric Quality of Life (PedsQL) Family Impact Module 1 year post-op(1 year post splint implantation)
- Pediatric Quality of Life (PedsQL) Family Impact Module 3 years post-op(3 years post splint implantation)
- The proportion of subjects with any device-related complication (DRC) at 6 months' post-implantation.(6 months post splint implantation)
- The proportion of subjects with any device-related complication (DRC) at 2 years post splint implantation(2 years post splint implantation)
研究者
Richard Ohye
Professor of Cardiac Surgery
University of Michigan
研究点 (2)
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