A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Device and procedure related adverse events
研究概览
简要总结
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome
详细描述
This clinical investigation is a study to evaluate safety and probable benefit of the Eclipse XL1 System in pediatric and adult subjects with short bowel syndrome. This study is a single arm study and will enroll subjects ages 3 months to 65 years old at up to 10 study sites in the United States. This study will be open label; treatment allocation will be known by the subjects, the Principal Investigator and his medical staff. Recruitment is expected to occur over the course of 24-36 months.
Device placement will be administered during a standalone procedure or a previously planned procedure that is otherwise needed by the study subject. Subjects may receive up to 2 devices at one time and/or have multiple procedures over time based on clinical necessity Study objectives will be monitored by reviewing patient nutrition, weight, and stool assessment data. The study device will also monitored by radiographic examination to confirm location of the device and assess the safety and probable benefit of distraction enterogenesis until the device is removed or passes out of the intestine naturally. Patients will be followed while the study device is in situ and at 3 and 6 months post device passing or removal. Subjects may or may not be discharged from the hospital while participating in the study, and investigators may recommend that a subject stay in-patient for a portion or the entire length of study, depending on subject health.
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
- 3 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has short bowel syndrome, defined as 50% or less of expected bowel length based on subject age and/or height, and measured at the time of the subject's prior intestinal resection.
- •Minimum residual bowel length of 3 cm.
- •Male or female patients aged 3 mo to 65 years inclusive
- •The subject, parent or legal guardian of the subject is able to read, understand, and is willing to provide informed consent.
- •The subject or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the subject to all clinic visits and complete all study related procedures (as determined by the investigator).
排除标准
- •Ultra-short bowel syndrome defined as less than 3 cm of bowel length.
- •Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis)
- •Evidence of active or prior Crohn's disease.
- •Primary intestinal failure (i.e., without loss or resection of intestinal tissue).
- •Coagulopathy, as defined by INR > 1.4 or platelets <
- •Known immunocompromised status including, but not limited to, individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.
- •Subject is determined by the investigator to be unsuitable for participation in this trial for any reason.
研究组 & 干预措施
Eclipse XL1 Coil Treatment Group
All subjects will be assigned to the XL1 Coil treatment group.
干预措施: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome (Device)
结局指标
主要结局
Device and procedure related adverse events
时间窗: 4 to 6 months
Incident rate of moderate or severe procedure and/or device related adverse events
次要结局
- Assess the lengthening of the small intestine(4 to 6 months)
- Improvement in overall nutritional status(6 to 12 months)
- Assess the lengthening of the small intestine(4 to 6 months)