Omega Partial Fundoplication: a new implant to treat GERD
Official title: Pivotal Clinical Study to Validate Early Outcomes of a Novel Implantable Device for Surgical Treatment of Gastroesophageal Reflux Disease
Funded at Aplos Medical INC · NIH-11409770 · Data updated 2026-11-12
A new implantable device called the Omega Partial Fundoplication (Ω-PF) aims to simplify surgery for GERD and improve quality of life for adults with reflux who don’t respond well to medicines.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Aplos Medical INC NIH-funded |
| Lab location | 1 site (Eden Prairie, United States) |
| Project start | May 1, 2021 |
| Project end | August 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $1,030,000 |
| NIH project number | 2R44DK127882-04 |
| Project ID | NIH-11409770 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with GERD who are candidates for surgical treatment and have not achieved durable relief from medications.
✕Less likely to help
Patients with conditions that contraindicate surgery or have anatomy unsuitable for this device may not benefit.
What this research studies
This project builds on prior short hospital stays and patients’ reported relief by testing a nitinol, flexible device that supports the esophagus without changing anatomy. Surgeons place the device around the lower esophagus and secure it with two sutures, allowing normal swallowing and reducing typical side effects. The study will advance from feasibility to a pivotal trial to gather the data needed for FDA approval and broader use. If successful, it could offer a safer, simpler alternative to traditional anti-reflux surgeries.
Why it matters
Potential benefit: If successful, patients could have a safer, less invasive option that improves reflux control and quality of life while preserving normal swallowing.
How similar studies have gone: Early feasibility data showed the device is well-tolerated and improves quality of life in participants.
Where this research is happening
-
Aplos Medical INC
Eden Prairie, United States Active
Researchers
- Principal investigator: Tihon, Claude Nmn — Aplos Medical INC
- Study coordinator: Tihon, Claude Nmn
Related research
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Creating a mobile app to help patients with acid reflux ask better questions about their health
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-
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-
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This project tests whether long-term acid reflux causes damaging protein clumps in esophagus cells of people with chronic GERD or Barrett's esophagus that can help drive esophageal cancer.
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This study is looking at how stomach acid can affect lung transplant patients and cause problems with their new lungs, hoping to find better ways to help these patients feel better and improve their treatment options.
-
POEM vs Heller myotomy with Dor fundoplication for achalasia
This trial tests POEM against laparoscopic Heller myotomy with Dor fundoplication to see which procedure better helps adults with achalasia.
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.