Pivotal Study to Evaluate the Safety and Efficacy of the Insides™ System in the Treatment of Subjects With a Double Enterostomy and/or Enterocutaneous Fistula and Type 2 Intestinal Failure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 22
- 主要终点
- Efficacy - the proportion of subjects who achieve a 50% reduction in total caloric intake obtained from parenteral nutrition measured at 30 days post randomization compared to baseline.
研究概览
简要总结
This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas. The device system functions simply to return the output from a fistula back into the distal limb of the intestine.
详细描述
The development of enterocutaneous fistulas are devastating consequences of surgery or surgical diseases. They cause excessive fluid and nutrient losses from the gut resulting in severe dehydration and intestinal failure mandating invasive medical therapies to improve survival. These disorders inflict a vast burden of suffering, morbidity, and mortality on patients, while extracting enormous per-patient resources from healthcare systems. Parenteral nutrition is often required, meaning prolonged hospital stay, an attendant risk of line sepsis, venous damage and thrombosis, liver impairment, and death.
There is a pressing demand for breakthrough technologies that can restore lost fluids and nutrients to the body in patients affected by enterocutaneous fistulas in order to reverse intestinal failure, eliminate the need for parenteral nutrition, prevent dehydration and renal injury, allow safe care in the community, enable chemotherapy completion, and restore quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •Able to provide written informed consent
- •Dependent on parenteral nutrition (PN)
- •DES/ECF with exposed afferent and efferent limbs visible on the abdominal wall
- •Minimum of 2 weeks post DES/ECF creation
- •Distal limb of DES/ECF opening can be intubated by a minimum 24Fr feeding tube (dilatation of orifice strictures is allowable)
排除标准
- •Insufficient distal access channel (distal limb) for device insertion
- •Bowel obstruction proximal to the DES/ECF
- •Small bowel obstruction, anastomotic leak, or perforation distal to the DES/ECF (diagnostic procedure such as gastrografin test, fistulograms, or similar must be performed, if there is a distal anastomosis with integrity not previously evaluated, to ensure that the subject is eligible)
- •Scheduled for DES/ECF reversal within 4 weeks of enrolment date
- •Current infection with Clostridium difficile colitis
- •Current infection small intestinal bacterial overgrowth (SIBO)
- •Signs or symptoms of systemic infection
- •Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis
- •Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson's disease, hypothyroidism
- •Known peritoneal metastatic disease prior to DES/ECF closure (acceptable if only discovered at time of closure)
- •Liver cirrhosis
- •Hereditary coagulopathy, e.g., von Willebrand disease
- •Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2)
- •Active implantable medical devices such as neuromodulation and cardiac systems
- •Metal stents implanted within 20cm of expected use of the controller
- •Women who are pregnant or breastfeeding
- •Subjects participating in an interventional clinical study within 30 days prior to randomization
结局指标
主要结局
Efficacy - the proportion of subjects who achieve a 50% reduction in total caloric intake obtained from parenteral nutrition measured at 30 days post randomization compared to baseline.
时间窗: 30 days post randomization
Between group comparison of the proportion of subjects who achieve a 50% reduction in the use of parenteral nutrition
次要结局
- Efficacy - Between group comparison of the time to discontinuation in the use of PN(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire(30 and 60 days)
- Efficacy - Between group comparison of the time to reduction in the use of PN(30 and 60 days)
- Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids(30 and 60 days)
- Efficacy - Between group comparison of the time to ostomy closure(30 and 60 days)
- Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies(30 and 60 days)
- Safety - Between group comparison of peristomal skin complications(30 and 60 days)
- Healthcare Utilization - Between group comparison of length of stay for index hospitalization(up to 30 days)
- Healthcare Utilization - Between group comparison of all cause hospitalizations(30 and 60 days)
- Healthcare Utilization - Between group comparison of hospitalizations due to dehydration(30 and 60 days)
- Device performance - The overall incidence of device related adverse effects(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory(30 and 60 days)
- Efficacy - Between group comparison of the time to reduction in the use of PN(30 and 60 days)
- Efficacy - Between group comparison of the time to discontinuation in the use of PN(30 and 60 days)
- Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids(30 and 60 days)
- Safety - Between group comparison of the incidence of serious adverse events(30 and 60 days)
- Efficacy - Between group comparison of the time to ostomy closure(30 and 60 days)
- Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies(30 and 60 days)
- Safety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI)(30 and 60 days)
- Safety - Between group comparison of peristomal skin complications(30 and 60 days)
- Healthcare Utilization - Between group comparison of length of stay for index hospitalization(up to 30 days)
- Healthcare Utilization - Between group comparison of all cause hospitalizations(30 and 60 days)
- Healthcare Utilization - Between group comparison of hospitalizations due to dehydration(30 and 60 days)
- Device performance - The overall incidence of device related adverse effects(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire(30 and 60 days)
- Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory(30 and 60 days)