Use of Mometasone Eluting Stent in Choanal Atresia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Assessment of Posterior Nasal Cavity
研究概览
简要总结
This study is to find out how well drug-eluting stents work as part of treatment for choanal atresia repair. Participants will be receiving surgical choanal atresia repair; half will get a drug-eluting stent placed, the other half will not.
详细描述
Objective
To determine the utility of mometasone eluting stents in the treatment of choanal atresia.
Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric Otolaryngology, Head and Neck Surgery
Study Design: Randomized, single blind control trial
Methods: This study will be a randomized, prospective single-blinded control trial. Inclusion criteria will include all subjects less than 11 years of age who are diagnosed with either unilateral or bilateral choanal atresia. Following enrollment, the patients will be randomized to either a control arm (no stent) versus an intervention arm (placement of drug eluting stent). Subjects will then undergo surgical repair of the choanal atresia with either no stent or a drug eluting stent placed. Multiple postoperative nasal endoscopies will be performed to assess size which will be reviewed and graded by two independent reviewers.
Analysis: Descriptive statistical analysis and multivariate analysis will be performed.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Subjects who are under 11 years old and have a diagnosis of choanal atresia will be included in this study.
排除标准
- Those subjects who are 11 years of age or greater or who do not have choanal atresia will be excluded.
研究组 & 干预措施
Stent
Subjects will undergo repair of the choanal atresia in the operating room with a drug eluting stent placed at the end of the surgical procedure. They will return to the operating room in 3-5 weeks for repeat nasal endoscopy with possible balloon dilation, which is standard of care within our institution. At this time in the operating room the intervention arm will have the stent removed. Following removal of the stent, photodocumentation of the posterior nasal cavity and nasopharynx will take place to assess the size (standard of care).
Subjects will then follow up and undergo a bedside or outpatient nasal endoscopy and nasopharyngoscopy (standard of care) at the following approximate intervals 1 month, 6 months, 12 months (these are not exact time periods as clinic scheduling can sometimes be 2-3 months on either side of these time stamps).
干预措施: Drug-eluting Stent Mometasone (Drug)
结局指标
主要结局
Assessment of Posterior Nasal Cavity
时间窗: 12 Months
Once photodocumentation from followup visits is collected, the images will be collected by a member of the team and given to two independent expert blinded reviewers for assessment of the size of the posterior nasal cavity. The picture will be obtained from the same anatomical position for each scope (the posterior portion of the inferior turbinate) and compared to the picture immediately after surgery of the posterior nasal cavity to assess any changes in size. Reviewers will assess the size of the posterior nasal cavity in each subsequent scope and categorize subjects based on the following sizes (0-50%, 51-75%, 76-100%).
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT03605537
- 其他研究编号
- 2018-1813
日期
- 首次提交
- (8年前)
- 首次发布
- (8年前)
- 主要完成日期
- (6年前)
- 研究完成日期
- (6年前)
- 最近核实
- 最近更新
- (5年前)
监管与共享
- FDA 监管药物
- 是
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Data will be retained in an identifiable state in a password protected database for potential unspecified research. If this data were to be used in the future, a new IRB would be submitted.