# Percutaneous Ultrasound Gastrostomy: Clinical Evaluation of a Novel Method for Feeding Tube Placement

> **NIH NIH R44** · COAPTECH, LLC · 2020 · $590,458

## Abstract

The goal of this project is to test a potentially safer, more accessible method for placement of
gastrostomy feeding tubes. Millions of patients worldwide require enteral nutrition, and
hundreds of thousands of gastrostomy (feeding tube placement) procedures are performed
annually in the United States alone. Key patient populations receiving gastrostomy
procedures include Medicare enrollees in the US, pre-term infants in developing nations, and
individuals managing chronic conditions which are increasing in incidence, such as cancer
and stroke. The current standard of practice for placement of nearly all feeding tubes
worldwide is called the Percutaneous Endoscopic Gastrostomy (PEG) method. PEG is
costly, complex, and potentially risky to perform, as it is performed in a surgical suite about
85% of the time, requiring specialty providers and sophisticated imaging instruments.
We have invented a new device and method, using magnets and low-cost ultrasound, called
the Point-of-Care Ultrasound Magnet Aligned Gastrostomy (PUMA-G) device, which will
improve and simplify the gastrostomy procedure on many dimensions. The PUMA-G device is
applied using the Percutaneous Ultrasound Gastrostomy (PUG) procedure. The most important
difference between our method and PEG, is that the PUMA-G device will allow 80% of all
gastrostomy procedures to be performed at the patient’s bedside - without specialist
consultants, expensive imaging, and surgical suite time (for the remaining 20% of cases, the
PUMA-G device will be contraindicated, and a conventional PEG may be performed).
Migration of methods from the surgical theatre to the patient bedside has successfully
occurred for many different specialty procedures over the previous two decades, and in each
instance has led to substantially reduced cost and improved patient satisfaction, with
comparable or better safety outcomes.
The PUMA-G device has demonstrated feasibility in live GLP canine studies, human
cadavers, and benchtop studies, and has a clear regulatory pathway laid out through
meetings held between CoapTech and the FDA. In this Phase 2 SBIR project we will conduct
a clinical study in 40 critical care patients to establish safety and feasibility of the procedure
in a live setting. We will also develop a rigorous Human Factors-informed training program for
the use of the PUMA-G device. Successful completion of this project will form the basis for
safety and cost justifications and provide vital data for clinical adoption in order to bring this
new method significantly closer to improving outcomes and experience for patients
worldwide.

## Key facts

- **NIH application ID:** 9985801
- **Project number:** 5R44DK115325-03
- **Recipient organization:** COAPTECH, LLC
- **Principal Investigator:** Howard Carolan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $590,458
- **Award type:** 5
- **Project period:** 2017-09-15 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9985801

## Citation

> US National Institutes of Health, RePORTER application 9985801, Percutaneous Ultrasound Gastrostomy: Clinical Evaluation of a Novel Method for Feeding Tube Placement (5R44DK115325-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9985801. Licensed CC0.

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