Pediatric Percutaneous Ultrasound Gastrostomy Technique

CoapTech

Status: Enrolling

Conditions: Pediatric Disorder; Gastrostomy Complications; Gastrostomy; Ultrasound

Treatments: Device: Percutaneous Ultrasound Gastrostomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05966311

220001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Percutaneous Ultrasound Gastrostomy (PUG)

Experimental group

Description:

Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist

Treatment:

Device: Percutaneous Ultrasound Gastrostomy

Percutaneous Radiologic Gastrostomy

No Intervention group

Description:

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.