Flexible balloon overtube to make upper‑GI endoscopic cancer removal safer
Official title: Balloon Overtube Access Device for Improved Interventional Endoscopy in the Upper GI
Funded at Aspero Medical, INC. · NIH-11132728 · Data updated 2026-11-12
This project is building and testing a flexible balloon overtube to help doctors remove cancerous and precancerous lesions from the esophagus and stomach more safely and easily.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Aspero Medical, INC. NIH-funded |
| Lab location | 1 site (Boulder, United States) |
| Project start | July 15, 2024 |
| Project end | June 30, 2027 |
| Funding year | 2025 |
| Award (this year) | $1,022,219 |
| NIH project number | 5R44DK136377-02 |
| Project ID | NIH-11132728 on NIH RePORTER |
Who could benefit from this research
✓Could help
People with cancerous or precancerous lesions in the esophagus or stomach who are candidates for endoscopic removal are the most relevant patients.
✕Less likely to help
Patients whose tumors require open surgery, who have lesions in the colon or rectum, or who are not candidates for endoscopy are unlikely to benefit from this device.
What this research studies
The team will design and refine a flexible balloon overtube that supports endoscopic submucosal dissection (ESD) and improves endoscopic mucosal resection (EMR) in the upper gastrointestinal tract. Engineers and clinicians will complete preclinical bench and animal testing, finalize the design, and freeze the device for verification and validation. The goal is to make ESD easier and reduce risks like perforation so more endoscopists will choose the more complete removal technique. If preclinical milestones are met, the sponsor will prepare a 510(k) submission to seek FDA clearance for clinical use.
Why it matters
Potential benefit: If successful, the device could make removal of upper‑GI cancerous and precancerous lesions safer and more complete, lowering complication and recurrence rates.
How similar studies have gone: Endoscopic submucosal dissection is already shown to achieve higher complete removal and lower recurrence than EMR, but balloon overtube devices are a newer engineering approach with limited clinical data so far.
Where this research is happening
-
Aspero Medical, INC.
Boulder, United States Active
Researchers
- Principal investigator: Rentschler, Mark — Aspero Medical, INC.
- Study coordinator: Rentschler, Mark
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.