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IPEG - NoLapse- The Stomal Prolapse Prevention Device - Caressa Chen
With Dr. Carissa Chen & Dr. Samir Pandya · hosted by Dr. Em Gootee & Dr. Todd Ponsky
Educational content from recorded physician discussions — not medical advice. Talk to your (or your child's) care team about your situation.
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What the experts said
Up to 8% of ostomy patients will experience prolapse at least once
Stomal prolapse requires frequent emergency room visits, hospitalizations, and even emergent surgeries
The No-laps device is made of biocompatible silicone
The device is semi-flexible yet collapsible, easy to insert or remove at bedside without anesthesia
The device is atraumatic to bowel
Pre-clinical studies demonstrated the No-laps can effectively prevent stomal prolapse without obstructing stool passage
Force testing proved significant force is required to accidentally dislodge the device
The No-laps is compatible with use of ostomy appliances
The device has been successfully used in three emergency human cases
The final design will include six different sizes
The team plans to proceed with human clinical trials in the de novo pathway for FDA approval
The team is currently working on pre-clinical studies using a porcine model
The No-laps device is made of medical-grade silicone
Ostomy Cures in Europe has a titanium-based device prototype in clinical trials
The Ostomy Cures device has a plastic lid that can be controlled to empty the bag or stoma
Ostomy Cures suspended all clinical trials because of COVID