Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Need of re intervention
研究概览
简要总结
The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis. The main question[s] investigators aim to answer are:
- What is the need for reintervention and time to reintervention in participants with benign airway stenosis with simple stenosis who receive spray cryotherapy plus balloon dilatation versus standard of care alone?
- To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone.
Researchers will compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis to see if it reduces the need of re intervention.
Participants will surgery and receive one of the two interventions.
详细描述
Investigators propose a single center, single-blinded (patient), randomized 1:1 trial comparing SCT plus Balloon dilatation (experimental group) vs SoC alone (control group). Investigators aim to recruit 50 patients.
Study will span 2-year duration with 1 year recruitment. Follow up at 6 weeks, 3 months, 6 months, 12 months. The patient's airway will be either a laryngeal mask airway or a rigid bronchoscopy for passive venting and gas egress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
- •Stenotic airway of diameter < 1cm.
排除标准
- •Complex stenosis, cartilage involvement (malacia or fracture).
- •Patients with giant bullae (> a third of hemithorax) or bullae >3cm.
- •Concurrent tracheoesophageal fistula, active tracheal malignancy.
- •Presence of concomitant upper airway obstruction.
结局指标
主要结局
Need of re intervention
时间窗: Need of re intervention in two years
Number of patients that require new intervention for the benign airway stenosis.
次要结局
- Time to re intervention(Two years)
研究者
Adnan Majid, MD
Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School,
Beth Israel Deaconess Medical Center