Alicia Morgans: Hi, my name is Alicia Morgans and I'm a GU medical oncologist at Northwestern University in Chicago in the United States. I am so excited to have here with me today, Dr. Gonzalo Vitagliano, who is the Head of Oncology and Urolaparoscopy and the Department of Urology at the Deutsches Hospital in Buenos Aires, Argentina. He's here to talk with us today about his development of a surgical simulator for laparoscopic partial nephrectomy for renal cell cancer. I'm so excited to have you here today. Thank you for being here with us.

Gonzalo Vitagliano: Hi, Alicia. It's a pleasure to be here, and I'm so, so happy to share this with you. We talked offline a little bit about it. So to give the audience a bit of context, there is a need for more realistic surgical training. The traditional approach of on-patient training is evolving nowadays to more and more use of simulators and more complex platforms. That's in all types of surgery, but especially in urology. As urologists, we have two or three major very complex procedures. One of them is partial nephrectomy. There is a need to train outside of the patient for fellows and for residents. Minimally invasive partial nephrectomy, either done through laparoscopy or through the robotic platform for incidental renal masses, requires a lot of expertise. So the idea was to develop something that could allow fellows and residents to train, of course, help the patient get better results, better surgeries with safer procedures. And of course, for our patients to have a safe procedure is mandatory.

So we came up with this model, which is made out of rubber and silicon all put together and printed out on 3D machinery. And it mimics between 87 and 90% of the elastic properties of the renal parenchyma. So we put up a lot of scenarios, different for like easy scenarios for more novice surgeons and more complex tumors, intraparenchymal tumors, complex tumors with many vascular vessels. The idea was to build a platform that could allow an expert or a novice surgeon to train in this.

So we came up with this. We named it Urotrainer, of course, as we mentioned, and we're very happy about this. And this is the first commercially available training platform. Other simulators we know about exist, but they lack haptic feedback. As a surgeon, you need to feel in your hands what you're operating on. So even though there's a lot of high-tech technology out there that can allow for surgical training, none of them give the haptic feedback of the real thing. So we're very proud of it. We have done the validation of the model. We did a multi-institutional validation along with the Italian hospital and the German hospital. We put together a group of experts and a group of novice surgeons, and we validated the procedures. And we're so happy. We're going to share our results on the AUA, in the upcoming AUA, and the results are awesome. Results are awesome because they're the real deal.

Alicia Morgans: I think it's just so exciting. As we think about connecting folks all over the world, really, which is something that these simulations can allow you to do, it's really taking that surgery to the next level. And we're way past the time where surgeons had to try to find somebody to practice on. I mean, in the Middle Ages, I remember hearing stories about those kinds of things.

It's wonderful that you're actually able to create something that can be useful for people to practice outside of humans so they can really get those skills. Can you tell me a little bit about how you're able to do vasculature? I mean, that seems really complicated. And how do you mimic the equipment that needs to come in and get to your model?

Gonzalo Vitagliano: Well, yeah. I have one in my hand, of course.

Alicia Morgans: Great.

Gonzalo Vitagliano: And as you see, it's all covered in fat. Fat is sticky and gooey as real fat is. Here's a little window so you can see the renal parenchyma. But what we've done is we've made a lot of molds of the different structures and then put them all together for each one of the kidneys. So it's a very complex procedure to make one. But the thing is that it really mimics the real thing. We use the model with real-life surgical instruments. You don't need anything else. You can have a pelvic trainer. In every hospital and every simulator training facility, there are pelvic trainers. We developed a specific pelvic trainer for the Urotrainer, which is meant to be specifically for this, but I mean, you don't need it. You can just purchase this and hook it up to a robot or a standard pelvic trainer.

And what was very challenging for us is that we got the elastic properties of the products right. It was like 87, 90% similar to porcine and human kidney. The thing is that if you shoot for 100%, you cannot pay it. It gets way too expensive, because you need other materials. So the compromise was to do something that our residents and our fellows could train with that was the closest thing to the real deal. So when we did this, we compromised on 90%, which is pretty high, and we started doing all our lab tests and asking what the feel was for different surgeons, both experts and not so. And we got the results. The suture is so close. You're going to see it on the videos. And the feel of when you're cutting, it just feels like you're operating. The thing is that it doesn't bleed for now. We have one in our pipeline for next year that it's essentially going to bleed, but I cannot show it to you now.

Alicia Morgans: That's so exciting. It sounds like something even I could try, but since I can't even hem a skirt, I better avoid it. Why don't we look at some of your imagery? I know you have slides to share with us.

Gonzalo Vitagliano: Let's go. Okay. As we mentioned, and we were talking before, we all learned by seeing a procedure, helping one, and then doing one. These principles were established by Halsted. Halsted lived in 1852. So we cannot believe that we are going to be training in 2020 with the same principles that, I mean, this was a genius, right? But things have evolved.

So here's the model. It's also linked to augmented reality, so you can navigate through your iPad or your phone, whatever you think you're using, as a screen. And this is how it looks like. Let me show you. Let me run some videos. Here is the anterior 35 millimeter mass. And as you see, the fat has been removed. What allows for this is to have a novice surgeon remove the fat, which is like the first step, and then the more advanced surgeon can do the procedure. And as you see, the procedures are that easy. And then there's one like intrarenal tumors or hilar tumors that are more complex.

When you suture, let me show you that. Here's a running suture with a barbed thread. Here you see the vascular pedicles. We're suturing it. You can use a clip or you can suture it. And the amended reality shows you exactly where you are going to find your blood vessel.

Here's another one. Here's the polar tumor. Let's go through this one completely. Maybe we can edit afterward, but it looks very good. And you can check for margins. You can check for errors. During the validation we did, we monitor that. And of course, if this was just a toy, there would be no difference between a skilled surgeon and a novice. But the thing is that it mimics the real thing so close that you can see all the errors that the apprentice is doing while comparing it to a more expert surgeon.

Alicia Morgans: That is really impressive. So as a non-surgeon, I don't normally look at tumors from this angle, but it looks like even the coloring. I mean, I'm sure it's not exact, but I mean, you've got the fat covering. I mean, it really looks like what you must see inside your illuminated cavity when you're really trying to do these surgeries.

Gonzalo Vitagliano: Exactly.

Alicia Morgans: This is really interesting. And it looks to me like the people demonstrating must be pretty expert because they're doing some nice stitching.

Gonzalo Vitagliano: I'm not going to tell you who it is.

Alicia Morgans: Very good. Wow.

Gonzalo Vitagliano: So here you can see, as I will show you before, the first tumor. This is the renal seven, eight, so tumors are separated through the complexity. The idea was to accommodate as many tumors that we could in a real size kidney. So the ratio is one-to-one. We didn't want to do a huge kidney. We wanted to do something that was exactly the same. So we put this together with a lot of information of surgeries that we've been doing through the years. And here's what I was telling you before, that the elastic model, not only the complexion, but the traction is very, very similar between Urotrainer and the human person. Here you can see how the blood vessel comes up, how you can isolate it, and practice your clipping or your suturing.

And you can train for margins, as it's shown in there. You can train for time. You can train for quality. It's awesome that you can train without feeling you're putting anyone at risk. So our idea is to prove that this is going to be reflected in our fellows' and residents' skills, and of course, in patient complications. So the idea is to establish a program for the surgeon to first train on Urotrainer before he even gets close to a patient.

Alicia Morgans: This is really interesting. So how do people who are not at your institution have access to this kind of training? Is there a way to gain access? I know you're going to be showing it at AUA and really describing it, but how do others get access?

Gonzalo Vitagliano: Yes, well, we put together two kinds of access. First, you can just purchase the models through our engineers. They're going to be selling it. And also, we provide courses. So you can purchase the course where you have training, and something good came out of COVID. We learned that we can do things from far, far away. And right now we have some hospitals that are being trained in Argentina through this platform. And they're mentoring through an iPad or via Zoom. So there's no problem with that.

And also, it came clear also during the pandemic that a lot of fellows and residents were losing training because these surgeries, most of them are elective. So, I mean, you may observe some renal tumors for a couple of months. So a lot of patients chose to observe their tumors and not go into surgery while in the pandemic. So a lot of training also was lost. So this comes to fill that gap, also, and through the technology nowadays, where you can mentor and tutor and you can do courses through these platforms, we can train that way, also. So maybe you have experts in your site. They just want to purchase and use the Urotrainer. That's fine. Or maybe in some places where the surgeries have not been so well-developed, they can purchase the course and all the training. So there are two ways around it.

Alicia Morgans: That's fantastic. So what would your message be to folks who are interested and who are excited about the Urotrainer? What's your take-home message from this presentation?

Gonzalo Vitagliano: Yeah, we have data that proves that it helps. We have data that proves that it's realistic. And nowadays we have to change the paradigm of how we train. I mean, we need for our patients to be safe, and even surgeries have been even evolving. They become more complex, right? So we have to keep up with that. So if you want to train for complex surgeries, this is a new instrument, a new platform. You can just go to our website and request the training or request the product. That's no problem. Urotrainer.com.

And also, stay in touch, because we're putting together an app that is going to monitor your training and that it's going to help, not only in the trainings but in the OR. And it's going to be tracking, track your surgeries, track your training. And also, we've also developed the VK1 Advanced, which is for more skilled surgeons, and tumors are all very complex. We have tumors that are less dense, so they break easily. We have tumors that are not rounded exactly, so they're not predictable. And tumors that are more intrarenal. So the VK1 Advanced is coming up. And also we're going to show it in the AUA, along with the app. So the idea is to put up together a community of surgeons that need and find training through our platform.

Alicia Morgans: I have a feeling this is only the beginning for you, too, Gonzalo. This is pretty fantastic. I think will really transform the ability, as you said, for people near and far to train on these techniques, even when we are so isolated. But maybe kidney cancer is just the beginning. Maybe you'll move on to other GU cancers and challenge not just those inside your institution, but worldwide. This is absolutely phenomenal. Congratulations on the hard work that you put into this, and good luck on your AUA presentation. I'm sure it will be very well received.

Gonzalo Vitagliano: Thank you so much. It's been a pleasure.