NCT03997994进行中（未招募）不适用
Drug-Coated Balloon for the Treatment of Symptomatic Chronic Benign Biliary Stricture
GIE Medical1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年5月12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
- 8
- 试验地点
- 1
- 主要终点
- Freedom from Biliary Stricture Re-intervention
研究概览
简要总结
DIGEST 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 biliary tract stricture.
Up to 15 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 biliary stricture with postoperative injury or PSC or anastomotic-stricture; and indicated for ERCP procedure.
- •Restenosis after plain balloon dilation with at least 2 previous balloon dilation sessions and recurrence of biliary obstructive symptoms/signs or being managed with implantable prosthetics (e.g. plastic stents).
- •Greater than 40% stenosis of the biliary tract via ERCP.
- •Total serum bilirubin >2 mg/dL. Alkaline phosphatase level >3 times higher than normal level. *Note: This IC is waved if the patient is being managed with implantable prosthetics.
- •Type I, II, III and IV Benign biliary duct strictures. Dominant stricture being accessible by balloon catheter.
- •Stricture length <4 cm.
- •Not currently listed for liver transplantation.
- •Voluntary participation and provided written informed consent.
排除标准
- •Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
- •Benign biliary strictures caused by pancreatic pseudocyst compression.
- •Malignant biliary obstruction.
- •Biliary obstruction associated with an attack of acute pancreatitis.
- •Inability to pass guidewire across stricture.
- •Subjects with cholangitis or bile leak or duct fistula.
- •Contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) or anesthesia or deep sedation or MRI.
- •Subject with an internal/external biliary drainage catheter.
- •Subjects with surgically altered gastro/duodenal/jejunal anatomy (e.g. Roux-Y-loop, choledochojejunostomy).
- •Subject with symptomatic duodenal stenosis (with gastric stasis)
- •Active systemic infection.
- •Allergy to paclitaxel or any components of the delivery system.
- •Currently undergoing required thoracic or abdominal cavity radiation therapy.
- •Has life expectancy <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.
- •Currently participation in another pre-market drug or medical device clinical study.
结局指标
主要结局
Freedom from Biliary Stricture Re-intervention
时间窗: 12 months
Biliary stricture re-intervention rate
Incident of serious balloon dilation-related complications
时间窗: 30 days
No serious procedure-related complications, including perforation, bleeding requiring invasive intervention or transfusion, cholangitis, pancreatitis, etc.
次要结局
- Change in Liver Function(Baseline, 7 days, 30 days, 3 months, 6 months, 12 months and 24 months)
- Time to the First Re-intervention(12 months and 24 months)
- Technical Success(0 months)
- Biliary Stricture Diameter(Baseline, 6 months)
- Long Term Clinical Success (LTCS)(12 months and 24 months)
- Mean number of dilations(12 months and 24 months)
- Change in Existing Biliary Obstructive Symptoms(Baseline, 30 days, 3 months, 6 months, 12 months and 24 months)
- Sustained Clinical Success (SCS)(12 months and 24 months)
研究者
研究点 (1)
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