Pediatric Percutaneous Ultrasound Gastrostomy Technique
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-21
SponsorCoapTech
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Temperature ≥ 38 C
Systolic BP < 80 or > 180 mmHg
Heart Rate < 50 or > 160
Estimated abdominal wall thickness >3cm
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous Ultrasound Gastrostomy
DeviceUltrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Percutaneous Ultrasound Gastrostomy (PUG)Experimental treatment 1 intervention
Group B: Percutaneous Radiologic GastrostomyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
PUMA-G Pediatric System Device-Related Complication Rate
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
Time frame
up to 30 daysSecondary outcomes
1
Gastrostomy Procedure Complication Rate
The rate of other complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using standard of care Interventional Radiologic gastrostomy tube placement method
Time frame
up to 30 days2
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time)
The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by total fluoroscopic time (min).
Time frame
up to 30 days3
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)
The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by dose area product (microGy-m2).
Time frame
up to 30 days4
Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose)
The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by skin dose (mGy).
Time frame
up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
CoapTech
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Columbia University
Collaborator
Children's National Research Institute
Collaborator
Source ClinicalTrials.gov