NCT03886324进行中（未招募）不适用
Paclitaxel-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Intestinal Stricture
GIE Medical1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年2月25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
- 10
- 试验地点
- 1
- 主要终点
- Incident of serious balloon dilation-related complications
研究概览
简要总结
POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.
详细描述
The study is designed to determine the safety and effectiveness for drug coated balloon (DCB) for treating intestinal strictures.
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.
- •Subjects for whom the balloon dilation would be chosen in standard practice, and the scope could not pass stricture.
- •Recurrent to plain balloon dilation with at least 2 previous balloon dilation or stricturotomy sessions and recurrence of intestine obstructive symptoms/signs.
- •Symptoms of intestinal partial occlusion
- •Length of stenosis/stricture ≤ 7 cm
- •Up to 2 discrete strictures.
- •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.
- •Malignant bowel stricture.
- •Extrinsic benign bowel stricture due to adhesion.
- •Stricture complicated with abscess, fistula, ulceration or associated with mesenteric vessel thrombosis
- •More than 2 stenosis/stricture lesions.
- •Length of stenosis/stricture > 7 cm.
- •Stricture not accessible by endoscopy.
- •Suspected perforation of the gastrointestinal tract
- •Acute bowel obstruction requiring urgent surgical intervention
- •Low rectal or anal strictures
- •Severe coagulation disorders (platelets < 70000; INR > 1.8).
- •Active systemic infection
- •Allergy to paclitaxel or any components of the delivery system.
- •Life expectancy of less than 12 months.
- •Drug abuse or on chronic steroid therapy for comorbidities.
- •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.
- •Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
- •Currently requiring abdominal radiation therapy
结局指标
主要结局
Incident of serious balloon dilation-related complications
时间窗: 30 days
Perforation, bleeding requiring endoscopic or surgical interventions or blood transfusion, severe abdominal pain requiring medications, infection requiring hospitalization or IV antibiotics
次要结局
- Change in obstructive symptoms using the Obstructive Symptom Score (OSS).(30 days, 3 months, 6 months, and 12 months)
- Procedural technical success(Time of procedure)
- Percent subjects with improvement in Endoscopic Obstructive Scale (EOS)(6 months)
- Number of repeated stricture dilation procedures(30 days, 3 months, 6 months, and 12 months)
- Procedure success(6 months)
研究者
研究点 (1)
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