ColoSeal device to avoid temporary ostomies after rectal cancer surgery
Official title: Safety and Efficacy Trial of the ColoSeal ICD System for the Treatment of Rectal Cancer Patients
Funded at Averto Medical INC · NIH-11195700 · Data updated 2026-11-12
This project tests a minimally invasive device designed to help many rectal cancer patients avoid having a temporary ostomy after surgery.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Averto Medical INC NIH-funded |
| Lab location | 1 site (Fremont, UNITED STATES) |
| Project start | September 20, 2024 |
| Project end | August 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $928,967 |
| NIH project number | 5R44CA287615-02 |
| Project ID | NIH-11195700 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults undergoing rectal cancer surgery who would ordinarily receive a temporary diverting ostomy.
✕Less likely to help
Patients who already require a permanent ostomy, have locally advanced tumors involving the anal sphincter, or have other surgical contraindications may not benefit from this device.
What this research studies
As a patient, this work is testing a small, reversible device placed during rectal cancer surgery that temporarily replaces the function of a diverting ostomy. The device aims to protect the surgical connection while sparing most patients from living with a stoma and the need for ostomy care and reversal surgery. If a serious leak occurs, the device allows for safe delayed standard ostomy surgery so patients can still be managed conventionally. The trial will collect safety and effectiveness data from patients who would otherwise receive a temporary ostomy.
Why it matters
Potential benefit: If successful, the device could let many rectal cancer patients avoid temporary ostomies, improving quality of life and reducing complications and healthcare costs.
How similar studies have gone: This is a relatively new, device-based approach with limited prior clinical data, so it is more novel than widely proven.
Where this research is happening
-
Averto Medical INC
Fremont, United States Active
Researchers
- Principal investigator: Fong, Kenton Dodyan — Averto Medical INC
- Study coordinator: Fong, Kenton Dodyan
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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.