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May 01, 2024

Stomtop - New Tech Development and Testing in Israel

This topic is about a new device called the StomTop, which is currently being tested in Israel. The device is designed to be partially inserted into the stoma, acting as a seal or valve. This could potentially eliminate the need for external adhesive wafers and bags. The device uses a soft, collapsible insert that flares open inside the stoma to create a seal, while still allowing gas and output to be managed.

Here are some thoughts and advice shared by people discussing this new device:

1. Concerns about leakage: Some people are worried that the device might leak because stomas are naturally moist, and output could seep around the insert.

2. Insertion worries: While some medical procedures involve inserting instruments into stomas, the idea of self-insertion is intimidating for many. They would prefer a stoma nurse to handle it.

3. Device displacement: There are concerns about what might happen to the device during sneezing or coughing, as these actions could potentially displace it.

4. Intrastomal insertion risks:
- Inserting anything into an ileostomy can be risky, potentially damaging the small intestine, increasing infection risk, or causing obstruction. Generally, only dilators for stenosis are accepted.
- The natural movement of the bowel, known as peristalsis, can push a plug or insert out or pull it deeper, and this movement varies among individuals.

5. Sizing and seal challenges:
- The device must be the correct size to account for abdominal and visceral fat. Incorrect sizing could prevent the flared seal from anchoring properly.
- Fast, high-volume output might slip between the stoma wall and the flared end before a proper seal forms, leading to leaks.

6. Material and hygiene considerations:
- The device likely needs to be made from medical-grade silicone to minimize allergies and allow for collapse and expansion.
- There are questions about how long the device can be worn, how it should be cleaned, and the risk of infection.

7. Lessons from earlier stoma plugs:
- Previous stoma plugs worked for some but were discontinued due to issues like powerful peristalsis ejecting them and colonic tissue folding over or adhering to the device.
- Any intrastomal device must have a fail-safe to contain output if the seal is lost.

8. Possible benefits if issues are solved:
- The device could eliminate the need for adhesives, reducing skin irritation.
- It might stabilize the stoma, potentially preventing prolapse or retraction.
- It could be life-changing for those who cannot tolerate wafers.

9. Need for extensive clinical testing:
- Long-term trials are essential, especially for those with ileostomies and liquid output.
- There are legal and liability concerns, as the device could face lawsuits if injuries occur.

10. Customization and future technology:
- Some suggest that individualized sizing could be achieved through 3-D printing of silicone parts, making it feasible and cost-effective in the future.
See full discusison
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