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
Qualifiers
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
Treatments tested in this trial
- Percutaneous Ultrasound Gastrostomy
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
CoapTech
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Columbia University
Collaborator
Children's National Research Institute
Collaborator
Source ClinicalTrials.gov