Pediatric Percutaneous Ultrasound Gastrostomy Technique

Recruiting N/A Interventional Study
Gastrostomy Gastrostomy Complications Pediatric Disorder Ultrasound
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
0 – 21
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
CoapTech · Industry
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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.

Trial Locations
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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 ≤3c…
Contacts

Jack Kent, MPH

4102151638

jack@coaptech.com

CONTACT

Steven Tropello, MD

4348255184

steven@coaptech.com

CONTACT