Evaluation of Efficacy of Use of TubeClear® to Restore Patency to Occluded Enteral Access Devices in Pediatric Patients (Phase I)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Successful Attempts to Restore EAD(P) Patency
研究概览
简要总结
This is the first of three planned phases designed to evaluate the feasibility and tolerability of TubeClear® to restore patency in occluded Pediatric Enteral Access Devices. Based on preliminary data obtained from this phase of the study, subsequent phases will continue to evaluate feasibility and tolerability (Phase IIA) and ultimately compare efficacy of TubeClear® to the Children's Hospital of Philadelphia (CHOP) Standard Treatment to restore patency in occluded Pediatric Enteral Access Devices (EAD) (Phase IIB).
详细描述
Occluded enteral access devices (EADs) are a significant problem for pediatric patients, with occlusion rates ranging from 12.5% to 35%. Occluded EADs can lead to extended times of decreased energy intake, resulting in patients quickly exhausting their energy reserves and developing dehydration with electrolyte abnormalities. Current methods used to restore patency to an occluded EAD at The Children's Hospital of Philadelphia (CHOP) involve application of enzymes and chemicals (e.g., Clog Zapper), which have variable rates of timely success. If these methods are unsuccessful and patency cannot be restored, the EAD must be replaced and may require radiological intervention with exposure to radiation and contrast material. TubeClear® addresses this clinical need to safely and efficaciously restore patency to occluded EADs at the patients' bedside while the EAD remains in the patient. Additionally, this reduces the need to transport the patient to the radiology suite with subsequent exposure to radiation and contrast material for EAD location conformation after replacement.
Current Study (Phase I): Feasibility and tolerability of TubeClear® intervention in 15 consecutive eligible Subjects with occluded Enteral Access Devices who have not attained their 18th birthday.
Following successful completion of Phase I as deemed by the Institutional Review Board (IRB), the Study will proceed to Phase IIA and IIB to run concurrently.
Future Studies:
Phase IIA: Ability of TubeClear® intervention to restore patency in 15 consecutive eligible Subjects with occluded Enteral Access Devices who have not attained their 11th birthday.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between who have not attained their 18th birthday
- •Indwelling occluded EAD(P) that is either:
- •Nasoduodenal Tube (ND), Nasogastric Tube (NG), Nasojejunal Tube (NJ) composed of Polyvinyl Chloride (PVC) and Polyurethane 6 - 8 Fr, 38 - 140 cm cm; or
- •Nasogastric Tube (NG) (Corflo, Corpak MedSystems) used as a jejunal tube inserted through a gastrostomy tube, 6 - 8 Fr, 38 - 140 cm
- •GJ (AMT) 14 Fr, 38 - 140 cm (15 - 55 in)
排除标准
- •Ward of the state
- •Positive pregnancy test/ Pregnant females
- •Any active gastrointestinal abnormalities or malformations, including but not limited to infections, inflammation, obstruction and/or recent abdominal surgery or trauma
- •Constant dependency on the EAD(P) for a glucose source (e.g. hyperinsulinism states)
- •Unable to tolerate water volume needed for the EAD(P) flush
- •Allergies to the contrast agent(s) used in post-Intervention radiological imaging
- •Measured total length of EAD(P) less than 38 cm (15 inches) - from external port to EAD(P) distal end
- •Unknown length of EAD(P)
- •Attending physician declines enrollment based on clinical judgement
- •Subject attains 18 years of age during study duration
结局指标
主要结局
Number of Successful Attempts to Restore EAD(P) Patency
时间窗: Baseline to 5 minutes post-intervention
Feasibility will be defined as ability of the user to operate TubeClear® from clearing stem insertion into the occluded Enteral Access Device through activation to patency restoration. Successful restoration of patency will be defined as the ability to flush the EAD(P) with 10ml of air within five minutes following the intervention by the investigator.
次要结局
- Change in Age-Appropriate Pain Score(Baseline to 3 days post-intervention)