Recruiting

Observational Study

Sponsor:

CoapTech

Code:

NCT05966311

Conditions

Gastrostomy

Gastrostomy Complications

Pediatric Disorder

Ultrasound

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Percutaneous Ultrasound Gastrostomy

Study Details

Brief 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

Study ID

NCT05966311

Start date

Jul 7, 2023

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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 ≤3cm
  • Indication for gastrostomy tube placement, with or without jejunal access tubing via gastrostomy tract, determined to be present for any of the following reasons:
  • Anatomic: Ear, nose, or throat abnormalities (Pierre-Robin sequence cleft lip palate)
  • Neurologic: Head trauma, Cerebral palsy
  • Bowel Disease: Short Bowel syndrome, intestinal dysmotility, inflammatory bowel disease, malabsorption
  • Failure to Thrive: Cystic Fibrosis, Cholestasis, AID, Chronic renal failure, and food refusal
  • Patient determined to be an appropriate candidate for PUG, PEG, or PRG by the clinical care team
  • Anticipated discharge > 24 hrs following gastrostomy

Exclusion Criteria:

  • Temperature ≥ 38 C
  • Systolic BP < 80 or > 180 mmHg
  • Heart Rate < 50 or > 160
  • Estimated abdominal wall thickness >3cm
  • Coagulopathy defined by INR > 1.7 or Platelets <50,000
  • Presence of a contraindication to being in proximity to a magnet (e.g. implantable metallic device).
  • History of prior gastrostomy, gastrectomy (partial or complete), or abdominal trauma or upper-abdominal surgery.
  • Scoliosis
  • Atypical organ placement including microgastria
  • Involvement in other investigational trials within 30 days prior to screening,
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
  • Patients with HgB < 7g/dL, or fluid resuscitated within 48hrs prior, or received blood transfusion within 48hrs prior, or active life threatening GI bleeding
  • Esophageal Diseases: Atresia, stricture, caustic ingestion
  • Spinal anomalies or atypical organ placement
  • Any other medical condition(s) that may put the patient at risk or influence study results in the investigator's opinion, based on the performance of a pre-procedural assessment.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Percutaneous Ultrasound Gastrostomy

Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jack Kent, MPH

4102151638jack@coaptech.com

Steven Tropello, MD

4348255184steven@coaptech.com

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Bhupender Yadav, MD

202-476-4252byadav@childrensnational.org

Nyph/Cumc

Recruiting

New York, New York, United States, 10019

Contacts

Joshua Weintraub, MD

212-326-8874jw750@cumc.columbia.edu

Children's Hospital Of Phildelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Anne Marie Cahill, MD

267-425-7118CAHILL@chop.edu

More Information

Sponsor

CoapTech

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Gastrostomy
  • Pediatric Gastrostomy
  • Device Feasibility
  • Device Safety
  • Ultrasound
  • POCUS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by CoapTech on 2026-07-31.