Ultrasound-guided pediatric G-tube device to improve safety and ease of use
Official title: Optimization of the clinically-successful Pediatric PUMA-G ultrasound gastrostomy device for safety, efficiency, human factors, and market-readiness.
Funded at Coaptech, LLC · NIH-11409150 · Data updated 2026-11-12
A new ultrasound-guided G-tube system for children aims to make feeding-tube placement safer, quicker, and easier by reducing radiation and avoiding traditional operating rooms.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Coaptech, LLC NIH-funded |
| Lab location | 1 site (Baltimore, United States) |
| Project start | September 20, 2019 |
| Project end | June 30, 2029 |
| Funding year | 2026 |
| Award (this year) | $1,097,977 |
| NIH project number | 2R44DK123910-04A1 |
| Project ID | NIH-11409150 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are children requiring gastrostomy tube placement, particularly those who would benefit from reduced radiation and a device designed for safe use in non-surgical settings.
✕Less likely to help
Patients who already have stable gastrostomy placements or those not needing radiative-free guidance may see limited impact.
What this research studies
This project advances a pediatric gastrostomy device (PUMA-G) with ultrasound guidance and a built-in microcamera to visualize the procedure in real time. It seeks final design refinements, rigorous verification and validation testing, and FDA 510(k) clearance, followed by a post-market data registry. The approach minimizes radiation exposure, eliminates the need for fluoroscopy or surgical suites, and focuses on user-friendly, safer insertion for children. Phase I/II results showed feasibility in 7 pediatric cases and promising reductions in radiation, supporting continued development toward market readiness.
Why it matters
Potential benefit: If successful, the device could become the new standard for pediatric G-tube placement, reducing complications and radiation exposure while simplifying the procedure.
How similar studies have gone: Previous small studies demonstrated feasibility and reduced radiation; this project intends to build on that by achieving market-ready, real-world use.
Where this research is happening
-
Coaptech, LLC
Baltimore, United States Active
Researchers
- Principal investigator: Carolan, Howard — Coaptech, LLC
- Study coordinator: Carolan, Howard
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.