Pediatric Percutaneous Ultrasound Gastrostomy Technique

Официальное название

A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Percutaneous Ultrasound Gastrostomy
  Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System

Первичные конечные точки

• PUMA-G Pediatric System Device-Related Complication Rate [Срок оценки: up to 30 days]

Вторичные конечные точки (6)

• Gastrostomy Procedure Complication Rate [Срок оценки: up to 30 days]
• Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time) [Срок оценки: up to 30 days]
• Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product) [Срок оценки: up to 30 days]
• Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose) [Срок оценки: up to 30 days]
• Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications [Срок оценки: up to 30 days]
• Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications [Срок оценки: up to 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Children's National Hospital — Washington D.C.
• Nyph/Cumc — New York
• Children's Hospital Of Phildelphia — Philadelphia

Идентификаторы

NCT: NCT05966311 · 220001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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