NCT03885310进行中（未招募）不适用
Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture
GIE Medical1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年2月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incident of serious balloon dilation-related complications
研究概览
简要总结
INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
详细描述
The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on esophageal stricture.
Up to 30 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years.
- •Benign esophageal stricture with diameter less than 10 mm (barium esophagram).
- •Dysphagia score of 2 to 4 (Ogilvie Dysphagia Score).
- •Recurrent stricture after at least 2 previous balloon/bougie dilation or stricturotomy sessions.
- •Stricture total length ≤ 7 cm. Tandem or adjacent strictures are allowed if the strictures are caused by the same underlining disease.
- •Ability to undergo periodic endoscopic follow-up.
- •Voluntary participation and provided written informed consent.
排除标准
- •Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- •Contraindication to endoscopy, anesthesia or deep sedation.
- •Benign esophageal stricture due to extrinsic esophageal compression.
- •Currently required chest radiation therapy.
- •Malignant esophageal stricture.
- •Stricture total length > 7 cm or esophageal strictures at multiple locations where the total stricture length exceeds 7 cm
- •Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, etc.
- •Active erosive esophagitis.
- •Present esophageal ulceration, perforation, leak, fistula, or varices.
- •Concurrent gastric and/or duodenal obstruction.
- •Active systemic infection.
- •Allergy to paclitaxel or any components of the delivery system.
- •Severe coagulation disorders or current use of anticoagulant for comorbidities.
- •Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
- •Received steroid injections into target stricture in the last 4 weeks
- •Intolerant to proton pump inhibitors.
- •Life expectancy of less than 12 months.
- •Unwilling or unable to comply with the follow-up study requirements.
- •Lacking capacity to provide informed consent.
- •Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, recent laparotomy, pharyngeal or cervical deformity, etc.
- •Currently participation in another pre-market drug or medical device clinical study.
结局指标
主要结局
Incident of serious balloon dilation-related complications
时间窗: 30 days
Adverse events such as perforation, bleeding requiring intervention, severe pain during swallowing, infection requiring hospitalization or IV antibiotics, dysphagia requiring re-intervention at determined by the attending physician
次要结局
- Numbers of additional esophageal dilation procedures(30 days, 3 months, 6 months, and 12 months)
- Time to first dysphagia symptom recurrence(30 days, 3 months, 6 months, and 12 months)
- Improvement in dysphagia score(30 days, 3 months, 6 months, and 12 months)
- Esophageal stricture diameter(30 days, 3 months, 6 months, and 12 months)
- Technical success(Time of procedure)
研究者
研究点 (1)
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