Pediatric Percutaneous Ultrasound Gastrostomy Technique

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
CoapTech
Study ID
NCT05966311
Status
Recruiting
Apply to this trial

Conditions

  • Gastrostomy
  • Gastrostomy Complications
  • Pediatric Disorder
  • Ultrasound

Eligibility Criteria

Sex
ALL
Age
0 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous Ultrasound Gastrostomy — DEVICE
    Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System

Study Details

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.

Key Dates

First listed
Jul 28, 2023
Start date
Jul 7, 2023
Status verified
Jul 2026
Primary completion
Aug 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Percutaneous Ultrasound Gastrostomy (PUG)
    Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist
  • No Intervention: Percutaneous Radiologic Gastrostomy
    A matched, retrospective control cohort of patients previously admitted to hospital for the placement of gastrostomy tubes by Interventional Radiology will be used to compare performance of the PUMA-G Pediatric System to standard of care.

Primary Outcome Measure

PUMA-G Pediatric System Device-Related Complication Rate [ Time Frame: up to 30 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Bhupender Yadav, MD
[email protected]
202-476-4252
Nyph/CumcNew YorkNew York10019
Joshua Weintraub, MD
[email protected]
212-326-8874
Children's Hospital Of PhildelphiaPhiladelphiaPennsylvania19104
Anne Marie Cahill, MD
[email protected]
267-425-7118

Find similar trials in Washington D.C., DC

By research site
Children's National Hospital· Washington D.C., DCNyph/Cumc· New York, NYChildren's Hospital Of Phildelphia· Philadelphia, PA

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