A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- PUMA-G Pediatric System Device-Related Complication Rate
研究概览
简要总结
The purpose of this research study is to test a new device called the PUMA-G Pediatric System. The research will measure if the device works well to safely aid doctors placing gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a feeding tube.
详细描述
This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the Percutaneous Ultrasound Gastrostomy (PUG) technique in the pediatric population.
A common method for placing gastrostomy tubes currently uses ionizing radiation to aid doctors in procedural steps. Excess radiation usage may present long-term risks to pediatric patients. The PUG procedure, using the PUMA-G Pediatric System, primarily uses ultrasound to guide gastrostomy feeding tube placement.
Up to 40 patients will be enrolled in the study and receive the PUG procedure using the PUMA-G Pediatric System. Following the procedure, patients will be followed during their hospital admission until discharge or up to 30 days. Data will be collected to assess how safe the procedure was and if the procedure used less radiation. Study subjects will be compared to a matched, retrospective cohort of patients who received standard of care gastrostomy tube placement by Interventional Radiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent must be obtained from the patient or a Legally Authorized Representative (ex. parent/guardian) before any study-specific assessment is performed
- •Weight ≥5 (Phase 0, Phase 1, Phase 2)
- •Weight ≥3kg and <10kg (Phase 3)
- •Estimated abdominal wall thickness ≤3cm
- •Indication for gastrostomy tube placement, with or without jejunal access tubing via gastrostomy tract, determined to be present for any of the following reasons:
- •Anatomic: Ear, nose, or throat abnormalities (Pierre-Robin sequence cleft lip palate)
- •Neurologic: Head trauma, Cerebral palsy
- •Bowel Disease: Short Bowel syndrome, intestinal dysmotility, inflammatory bowel disease, malabsorption
- •Failure to Thrive: Cystic Fibrosis, Cholestasis, AID, Chronic renal failure, and food refusal
- •Patient determined to be an appropriate candidate for PUG, PEG, or PRG by the clinical care team
- •Anticipated discharge > 24 hrs following gastrostomy
排除标准
- •Temperature ≥ 38 C
- •Systolic BP < 80 or > 180 mmHg
- •Heart Rate < 50 or > 160
- •Estimated abdominal wall thickness >3cm
- •Coagulopathy defined by INR > 1.7 or Platelets <50,000
- •Presence of a contraindication to being in proximity to a magnet (e.g. implantable metallic device).
- •History of prior gastrostomy, gastrectomy (partial or complete), or abdominal trauma or upper-abdominal surgery.
- •Scoliosis
- •Atypical organ placement including microgastria
- •Involvement in other investigational trials within 30 days prior to screening,
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •Patients with HgB < 7g/dL, or fluid resuscitated within 48hrs prior, or received blood transfusion within 48hrs prior, or active life threatening GI bleeding
- •Esophageal Diseases: Atresia, stricture, caustic ingestion
- •Spinal anomalies or atypical organ placement
- •Any other medical condition(s) that may put the patient at risk or influence study results in the investigator's opinion, based on the performance of a pre-procedural assessment.
研究组 & 干预措施
Percutaneous Ultrasound Gastrostomy (PUG)
Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist
干预措施: Percutaneous Ultrasound Gastrostomy (Device)
Percutaneous Radiologic Gastrostomy
A matched, retrospective control cohort of patients previously admitted to hospital for the placement of gastrostomy tubes by Interventional Radiology will be used to compare performance of the PUMA-G Pediatric System to standard of care.
结局指标
主要结局
PUMA-G Pediatric System Device-Related Complication Rate
时间窗: up to 30 days
A composite rate of the quantity and severity of device related adverse events will be quantified (i.e. linking complications to what are caused by the device) in the post-procedural period including any additional medical/surgical interventions to resolve
次要结局
- Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)(up to 30 days)
- Gastrostomy Procedure Complication Rate(up to 30 days)
- Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications(up to 30 days)
- Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time)(up to 30 days)
- Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose)(up to 30 days)
- Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications(up to 30 days)