# Percutaneous Ultrasound Gastrostomy: Clinical Evaluation of a Feeding Tube Placement Method in the Pediatric Population

> **NIH NIH R44** · COAPTECH, LLC · 2020 · $768,234

## Abstract

The percutaneous ultrasound gastrostomy (PUG) method has been made possible using the
PUMA-G System. The PUMA-G System was successfully developed by CoapTech, LLC with
SBIR Phase I support (R43 DK115325) leading to FDA 510(k) clearance for use in adults in April
2019. As of May 1, 2020, the PUMA-G adult device has been used for G-tube placement in over
90 patients at more than half a dozen medical centers in the US and Canada with no device-
related adverse events. Strong demand from clinicians has led the company to pursue a pediatric
application of the system to enable safe, ultrasound guided gastrostomy tube placement for
children. In collaboration with expert pediatric proceduralists from three premier pediatric
academic medical centers, and via funding from the NIH’s SBIR program (R43DK12391),
CoapTech made extensive advances to its original design in order to meet the unique clinical
needs of pediatric patients, including infants (<10kg) and children (10-30kg). Successful
engineering of the Pediatric PUMA-G System was confirmed in benchtop and animal models.
The proposed SBIR Phase II research project will advance the prototype sized for children
through phases of production into a medical grade device in order to evaluate its safety and
efficacy at three major, pediatric academic medical centers: Children’s Hospital of Philadelphia,
Children’s National Hospital, and Columbia New York Presbyterian Hospital. Assuming
successful results, the company would be able to use data gleaned in applications to FDA, and
to aid in marketing the Pediatric PUMA-G System to physicians with initial supporting data of
relative safety, cost advantages, time savings, and to accelerate development of an infant
PUMA-G System.

## Key facts

- **NIH application ID:** 10157361
- **Project number:** 2R44DK123910-02A1
- **Recipient organization:** COAPTECH, LLC
- **Principal Investigator:** Howard Carolan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $768,234
- **Award type:** 2
- **Project period:** 2019-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10157361

## Citation

> US National Institutes of Health, RePORTER application 10157361, Percutaneous Ultrasound Gastrostomy: Clinical Evaluation of a Feeding Tube Placement Method in the Pediatric Population (2R44DK123910-02A1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10157361. Licensed CC0.

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