Pediatric Percutaneous Ultrasound Gastrostomy Technique
NCT05966311 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-03-29
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.
Conditions
- Gastrostomy
- Gastrostomy Complications
- Pediatric Disorder
- Ultrasound
Interventions
- DEVICE
-
Percutaneous Ultrasound Gastrostomy
Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System
Sponsors & Collaborators
-
Children's Hospital of Philadelphia
collaborator OTHER - collaborator OTHER
-
Children's National Research Institute
collaborator OTHER -
CoapTech
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-07
- Primary Completion
- 2024-08-30
- Completion
- 2024-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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