A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrostomy
- Sponsor
- CoapTech
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- PUMA-G Pediatric System Device-Related Complication Rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
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,
Outcomes
Primary Outcomes
PUMA-G Pediatric System Device-Related Complication Rate
Time Frame: 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
Secondary Outcomes
- 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 (Dose Area Product)(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)