This is Dr. Reem Shariah. She is an Associate Professor of Medicine at Weill Cornell Medical College. She's also the Director of Interventional Endoscopy and Bariatric Endoscopy at Weill Cornell. And she has, as you saw with Dr. Thompson's slide, has had a lot of experience with publishing in suturing procedures, but she also has experience in non-suturing procedures as well. And today she's going to be talking about Procedureless Endoluminal Device, Jealousy, and Ellipse. Hello everyone, and thank you so much for the invitation. My talk is entitled Procedureless Endoluminal Devices. I'm going to be specifically talking about jealousy and the ellipse balloon. These are my disclosures. So when we look at the evolution of surgery and endoscopy, we went from open surgery to laparoscopic to most recently endoscopy has changed from again being diagnostic to the last 30 years becoming more therapeutic and then end surgery moving into the third space, like the notes technique, poems, et cetera. But what about the future? Are we moving to procedure less devices? And this is what we're going to be talking about. So we all know the advantages of endoscopic bariatric therapies. A lot of these compared to surgery are more appealing to the patient. What about no procedures? That's even more appealing. So we've seen this slide before, but basically it looks at the targeted endoscopic therapies based on location. So the ones in the stomach are really what caused more obesity reduction. And the ones in the small bowel have more of an anti-diabetic Nash effect. When we talk about balloons, there are different balloons out there and they can either be filled with air and nitric sulfide or saline, and they can either be placed endoscopically or placed via an NG light technique, which is what we'll see here. These are the balloons that are approved by the FDA. And we've heard about them in talks prior, so I won't belabor the point. Reshape has been voluntarily withdrawn off the market. So procedural is balloon. So this is a device that you insert with a capsule attached to a string sort of similar to putting in an NG tube or an oral gastric tube. You hook it up to 500 cc's of proprietary fluid and then the balloon gets inflated with this fluid. Now the valve here basically has some sutures onto it. And then over the four month period, the sutures disintegrate, the valve opens up and the balloon deflates and passes through the GI system. The company has gone through several iterations of the device. They've had to change the valve several times. And since its most recent iteration in 2017, they've had no issues as I'll show you. So these are the earlier studies out there that were published single center series. The biggest one was from Kuwait with 135, but essentially they show similar total body weight loss between 10 and 14% total body weight loss. The largest study to date was published last year and this is over 1,700 patients with a mean age of 38, mean BMI of 34. And you can see looking at their results that the mean TWL at the time of balloon removal, which is four months or 16 weeks is 14%. They also had significant reductions in excess weight loss and BMI. They had 52 or 2.9% intolerances requiring balloon removal and three bowel obstructions requiring surgery. And you can see that in this table here. You can also see that they had improvement in metabolic parameters and triglycerides and LDL and an A1C, even though it wasn't clinically significant. And these are the complications or the adverse events as I mentioned, one gastric perforation, one delay in gastric transit, one gastric outlet obstruction. This was a meta-analysis presented by the Mayo Group last year at DDW and it included identifying 160 studies, six were included. And what you can see here with the total body weight loss for the ellipse balloon is that at the time of removal or passage of the balloon, which is about four months, the total body weight loss is around 12.8%. And at one year, it's about 10.9%, which is similar to other fluid filled balloons. The adverse events, again, were low. The majority had intolerances requiring early removal and that's 2.3%. And that's similar to the data from the large study we just saw. Early expulsion by emesis in less than 1%. Again, same early deflations was less than 0.5%. And again, they had small bowel obstructions in three patients. Now, these were all the balloons that were done prior to 2017. So since the new iteration of the device, there hasn't been any issues. What about sequential placements? Django from Italy did this with the Obera balloon, but this is one of the first studies done with the ellipse balloon. And this is on 42 overweight and obese patients. They had their first treatment and then they had between one and five months without the balloon and then the second treatment. And then they recorded their weight afterwards. And what you can see here is that the weight loss on average for the first balloon was about 14.7 kilos. And this is balloon removal time. And then this is the second balloon. You can see that the subsequent weight with the second insertion is never going to be as good as the first. And you see that with other devices out there. And here you can see the total body weight loss. So 14% first balloon, 10% second balloon, and the total weight loss is around 22%. What about the ellipse plus intense medical weight loss program versus the intense medical weight loss program alone? This was a study that was presented at the ASMBS now a couple of years ago. So what you can see here is that there was statistically significant difference in the weight loss between the balloon and lifestyle group versus the lifestyle alone. So 13% versus 7.9 at the one year mark. And this table below, you can see the percentage responders. So more than 95% of patients had more than 5% total body weight loss, statistically significantly more than the lifestyle group. And then again, here, you can see the 10% and 20% total body weight loss, the percentage responders, all of these were statistically significant. So their conclusions were that the ellipse plus intense medical weight loss program leads to two and a half times the weight loss at 16 weeks versus the lifestyle alone. 93% of weight loss is maintained at 52 weeks. You see this plateau here. And 10 times more patients achieved more than 10% total body weight loss compared to the medical weight loss program alone. So the conclusion of the ellipse balloon studies is that the ellipse balloon demonstrates excellent safety and efficacy. You have less than 2% adverse events and less than 0.2% of serious adverse events in over 36,000 devices that were placed. 14.2% total body weight loss is the average weight loss in most studies. And it decreases down to about 10% at the one year mark. Ellipse sequential balloon placement enhances weight loss in overweight and obese patients. And small bowel obstructions occurred in 2016 with an earlier version of the device, none since 2017 with the current device. So moving on to GELASYS. The trade name is Planety. This is an FDA approved device. And the reason it's a device is because it is made from grass, which is generally recognized as safe and food building blocks, which we'll talk about in the next slide. So it's carboxymethylcellulose cross-linked with citric acid. They define it as a device because it's not absorbed, it's not metabolized, and it's has a mechanical mechanism of action. So they cleared it to be used in patients with a BMI of 25 to 40 when used in conjunction with diet and exercise. So here's what I mentioned, it's carboxymethylcellulose cross-linked with citric acid. And basically what happens is the patient has two to three capsules with 500 cc's of water 20 to 30 minutes before a meal. It expands, as you saw in the video prior, and it stays there delaying gastric emptying and digestion occurs, but it takes a lot longer. And then they are degraded in the large intestine water is absorbed and the remnants are eliminated from the body. So the GLOW study, which is the randomized double-blind placebo-controlled study was jealous versus placebo in patients who were given it lunch and dinner, and we were one of those sites here in the U.S. The inclusion criteria were 40 were overweight and obese patients that should be normal, glycemic, pre-diabetic, or with type 2 diabetes. And the primary weight loss was achieving a proportion of patients who had more than 5% total body weight loss. And what you see here is the results. This is the placebo group at the end of the study period had 4.3% total body weight loss versus 6.4 in the jealous group. So they achieved superiority, but they did not meet criteria to achieve a super superiority of at least 3%. So they were 2.1% difference and not 3% difference. And in this graph here, you can see the adjusted odds, which is around 2 in achieving 5% total body weight loss and 2.1 in achieving more than 7.5 total body weight loss. And again, 2.1 to achieve more than 10% total body weight loss. And this is the percent responders in each group of more than 5%, more than 7.5% and more than 10%, all statistically significant. In terms of change in baseline, you can see that everything was statistically significant, including their weight, BMI, excess weight loss, and the waist circumference. Interesting, they looked at early responders versus non-responders. They defined early responders as achieving more than 3% total body weight loss at week eight. And then they categorized patients into responders and non-responders. And what you can see here is that the responders achieved a 9.9% total body weight loss versus a 2.1 in the non-responders. In terms of adverse events, it's basically, I tell patients it's like methylcellulose or metamucil, but with a little bit more benefit. So you can see here is that the adverse event rate was similar between the two groups with one serious adverse event in the placebo group. And that's someone who had a colon polyp or colon cancer requiring surgery. In terms of adverse events, other adverse events probably related, the only difference was in the GI disorders. There was no difference in anything else. And when you look at the GI disorders, you can see that the jealous group had more abdominal distension, and this was statistically reaching or not reaching statistical significant, but they had clinically more abdominal distension, clinically more diarrhea. And none of these were statistically significant, but these were the mostly frequent complications was bloating and diarrhea. So the summary and conclusion from the GLOW study is that it's a randomized control study of six months duration. And other than an overall increase in adverse, gastrointestinal adverse events, there was no difference in both groups in serious adverse events. And so it's a very safe device to use. There were no clinically meaningful changes in blood chemistry, and it's a safe, well-tolerated therapy to aid in weight management. Thank you very much. I'll take any questions after.

procedureless endoluminal devices

Jealousy

Ellipse

balloons

weight loss