IPEG - NoLapse- The Stomal Prolapse Prevention Device - Caressa Chen

Um our last presentation for the IPEG segment comes from Dr. Carissa Chen from UCSF. She's going to present on a new invention they have called the No-laps, a stomal prolapse prevention device. I'm super excited to hear what Todd has to say about this one. And then uh but first we'll hear from Dr. Samir Pandya, who we already heard from from UT Southwestern right after the video. Hi, my name is Carissa Chen. I'm a general surgery resident and biodevice innovation fellow at the University of California, San Francisco. Today, I'll be presenting the No-laps, an anti-stomal prolapse device. I have no disclosures. Our device addresses the need of stomal prolapse, which, as you know, is very common. Millions of people worldwide have an ostomy, and up to 8% of them will experience prolapse at least once. Not only is this painful, but it's costly, requiring frequent emergency room visits, hospitalizations, and even emergent surgeries. Therefore, we came up with a device that can be inserted into a stoma to safely and non-operatively prevent prolapse. Our patent design includes two rings connected by a rod made of biocompatible silicone. The inner ring is inserted into the bowel lumen to prevent prolapse, and the outer ring rests on the abdominal surface to maintain the device in place. The device is semi-flexible, yet collapsible, meaning it's easy to insert or remove at the bedside without the need for anesthesia. In addition, it is atraumatic to bowel. In our preliminary pre-clinical studies, we've demonstrated that the no-laps can effectively prevent stomal prolapse without obstructing the passage of stool. In addition, using force testing, we proved that a significant force is required to accidentally dislodge the device. And lastly, the no-laps is compatible with use of ostomy appliances. Our device has been successfully used in three emergency in human cases. One such patient was two months old with a history of NEC and bronchopulmonary dysplasia, which precluded her from tolerating a surgical procedure. She had recurring stomal prolapse despite multiple bedside manual reductions. An early prototype of our device was used and inserted into the patient for 24 hours. She tolerated the device well, and even after the device was removed, did not have recurrence of stomal prolapse. We are currently working on additional pre-clinical studies using a porcine model. Concurrently, we are finalizing our design, which will include six different sizes and optimizing our manufacturing process. Ultimately, we plan to proceed with human clinical trials in the de novo pathway for FDA approval. Our team is composed of pediatric surgeons, trainees, and biomedical device specialists. We are also collaborating with a team of consultants well versed in product development. And that's all. Thank you for your time. I'm happy to take any questions. Dr. Chen, thank you so much for bringing that uh to our attention and I really enjoyed that talk, that presentation. And I got to tell you I've got a love-hate relationship with stomas because I love the fact that sometimes they're they're useful to divert and be safe and stuff, but I hate them that you have to get them just right. You either get them too tight and they stricture or you get them too big and they prolapse, so I have that. A few questions for you. Um, one, maybe I missed it, but what is the material that the uh device is made of? Uh, two, are you aware of um other competitors in the market? And if not, uh I'll be happy to share one with you. And then three, um I I have an idea about just using a single port. like a gel point port as the as the stoma prolapse device instead, like you just the same little single port. the gel point port, are you familiar with that thing? The green one or the purple one? The lars gel point. Applied medical. Yeah, you just put the thing there and just put the cap on and you're kind of done. So anyways, look forward to your responses. Thanks, Dr. Pandaya. Always good to hear feedback. So to your first question, it's made out of all silicone. It's all um uh ble silicone, medical grade. Second question intrigues me because I was going to say, no, we don't have any competition, but I feel like you're going to say something different. Um, but yeah, when we when we were uh looking up like the market and seeing what is available, we were kind of shocked by how few options there are, especially non-operative, um, for such a common problem in both the pediatric and adult population. Um, but I now I want to hear what you have to say. Yeah, so so this is um, you know, after the presentation that you gave at IPEG, you know, until then I hadn't really uh thought about this problem that intentionally and then most recently I had a couple of patients with uh IBD that ended up having prolapsed ostomies. And so maybe I I'm just a terrible surgeon, but that happened and they came up with this thing. They showed me a website in Europe. it's called Ostomy cures. And they have a prototype that they're doing clinical trial and I can find the website or somebody can find it right now and put it in the chat. And they have a titanium based device that implants into the stoma and then there's a uh plastic lid that comes on there. And that lid can be controlled to um uh empty the bag or empty the stoma and stuff. And um, it's all but it's all titanium based, which makes me a little nervous especially in the um IBD patients, but so I thought um, that'd be good for you to know. It seems like they've suspended all clinical trials because of COVID right now. Oh, I thought you were going to say because it wasn't successful. But that's cool. So I will tell you, you you totally burst my bubble uh as uh Ellen was that's why she wanted to know. I was thought I was a hero because I thought about putting a cut off the tip of a pacifier and put it in and then Iris Slim, our fellow in Cincinnati showed it to the stoma bag. And I was told I was like, oh my god, I'm amazing until Samir was like, uh dude, check this out. I was like, okay, I'm go hide in a closet again. Uh so I am so impressed. Um, I think this is going to be game changing whether it's this in its current form. There are a ton of questions for you. Um, we we are um, I'll give you a couple seconds to answer but we we unfortunately are over time, but I have one question. How can I get one for my patient? Right. People want that's what a lot of people are asking. Yeah. I wish I wish we were there yet. You know, it's we're realizing how um challenging that the road is from idea innovation to like clinical translation. So we're slowly, we're slowly getting there. Uh right now we're still sort of in the funding um route. Come on, just one, amongst friends. we could do it here you know really good animal studies long term with pigs first before we give them to your babies. But I we're. No, he's 15 years old. He's fine. Email me. Congratulations. Uh that was an amazing, amazing uh innovation and you should see the comments. Go over to the uh the actual show page and answer some of those. I think this is going to be something we really need. Thank you and Samir great uh commentary. Thank you.