CLEVELAND, OH (Ivanhoe Newswire) - They work their way through your body sending signals instead of delivering medicine. Right now smart pills are helping solve medical mysteries and can do a whole lot more. They are making a tough diagnosis much easier to swallow.
Having fun with his family until recently Jesse Krusinkski would have much rather stayed in his room than hang out with anyone.
"I started realizing I was getting more tired and more tired and I started getting pains in my stomach," Jesse Krusinski told Ivanhoe.
For two and a half years, doctors couldn't figure out the problem
"It was hard because there was nothing we could do, or give Jesse to make him feel better," Cheryl Krusinski, Jesse's mother, said
"We took him to the hospital and they did tests multiple times, upper GI, lower GI, they'd show us the pictures, they'd be completely clear," John Krusinski, Jesse's father, said.
"I was frustrated. I was tired of not knowing the answer," Jesse Krisinski said.
Then at the Cleveland clinic, Dr. Lori Mahajan recommended Jesse take one little pill.
"They swallow it with six to eight ounces of water," Lori Mahajan,M.D., fellowship director at the Cleveland Clinic Children's Hospital, explained.
The pillcam has a small camera on board. It wirelessly beams pictures to a recording device.
"The pillcam sends images, two per second to the recording device resulting in approximately 55,000 to 58,000 images in approximately eight hours," Dr. Mahajan said.
The pictures are downloaded so doctors can look deep into the small intestines frame by frame where traditional endoscopy tools can't reach. Without the pillcam surgery or other invasive procedures would be needed to get these images. Jesse's pictures revealed dozens of ulcers.
"And the doctor said it's definitely Crohn's and it was that simple," John said.
"This otherwise would be undiagnosable by any other technology," Dr. Mahajan explained.
And it's not just for older kids and adults, Dr. Mahajan said capsule endoscopy has been used in patients less than a year old.
"It's been an absolutely wonderful technology. It's being increasingly utilized," Dr. Mahajan said.
Meanwhile researchers in Ryukoku University, Osaka, Japan are working on the mermaid. It also takes pictures of the digestive system. But with its fin it can be guided to certain areas by remote control. Capsules like this could one day do much more than help with a diagnosis.
"They may be an option for removing polyps or treating blood lesions," Dr. Mahajan said.
At the University of Florida, antenna technology is printed on pills and can send a signal to a patient's cell phone to help them remember to take their medication. Once the pill's digested that data can be relayed to their doctor's phone, so they know what the patients taking and when.
Back at Jesse's house the games continue. He's now getting the treatment he needs for his Crohn's disease
"I hope that I can go into remission and live a normal life for a while," Jesse said.
The pillcam procedure costs about $1,500. Most insurance companies do cover the cost when it's used to investigate bleeding in the small intestines. She says for children the only major side effect of capsule endoscopy is the small chance of the pill getting stuck in the small intestines. The risk of that happening is less than five percent.
RESEARCH SUMMARY
BACKGROUND: Capsule endoscopy is a procedure that uses a tiny wireless camera to take pictures of your digestive tract. A capsule endoscopy camera sits inside a vitamin-sized capsule that you swallow. As the capsule travels through your digestive tract, the camera takes thousands of pictures that are transmitted to a recorder you wear on a belt around your waist. Capsule endoscopy helps doctors see inside your small intestine — an area that isn't easily reached with more-traditional endoscopy procedures. (www.mayoclinic.com)
RISKS: Capsule endoscopy is a safe procedure that carries few risks. In most cases, the capsule will leave your body when you have a bowel movement later in the day or within several days. In rare cases, the capsule can become lodged in your digestive tract. The risk is thought to be small — about one percent of people undergoing capsule endoscopy may experience capsule retention. Put another way, this means that for every 100 people who undergo capsule endoscopy, one person might still retain the capsule after two weeks. The risk may be slightly higher in people known to have Crohn's disease. (www.mayoclinic.com)
THE MERMAID: Researchers from Ryukoku University and Osaka Medical College in Japan have developed a self-propelled remote-controlled endoscopic pill. One centimeter wide and 4.5 centimeters long, it has a tail fin-like magnetic driving gear that allow it to "swim" through the digestive tract. It is controlled using a joystick and can be swallowed or inserted rectally. (www.medgadget.com)
ID CAP: eTect is a development stage company creating ID-Cap, an innovative solution that uses novel technology and the mobile internet to provide real-time verification of medication adherence. The patented ID-Cap system consists of three major elements: 1) biocompatible transponder tags affixed to the medication; 2) a reader worn by the patient, and; 3) a user interface application residing on a mobile phone. The ID-Cap is applied to the medicine, the patient ingests it, and upon ingestion the tag reports to a wristband reader worn by the patient. The tag breaks down into small particles and passes harmlessly through the digestive tract. The patient's cell phone will be running eTect's medication reminder app that will read the medication information, remind the patient to take the medication, and provide the medication adherence information to their clinical research or healthcare team.
INTERVIEW
Lori Mahajan, MD, staff physician at the Cleveland Clinic and fellowship director or pediatric gastroenterology and nutrition talks about a new technology called capsule endoscopy.
So talk about this capsule, how does it work? What exactly does it do?
Dr. Mahajan: Capsule endoscopy is an exciting, relatively new technology that is focused on evaluation of the small bowel. So it's very useful in looking at disorders of the small intestine, particularly causes of bleeding that are not able to be defined by other studies. Crohn's disease, which an inflammation of the small intestines, can affect you anywhere from your mouth to your anus, but often times will just be located in the small bowel and can be very difficult to diagnose. It's also useful for looking at polyp disorders involving the small intestines, unclear other causes of gastrointestinal bleeding, and even celiac disease.
How does this change the way you do things?
Dr. Mahajan: It's given us a non-invasive way of studying the small intestines. So, from a patient stand point, it's made it less invasive, has decreased the need for exploratory surgeries and possible laparotomy, and it's enabled us to, in a non radiation exposure way, to evaluate the small intestines.
So before you could swallow a pill and see what's inside, did you have to do surgeries?
Dr. Mahajan: Correct. Before PillCam was invented as a technology, we would either need to take long scopes, often times a pediatric colonoscope, and actually, from above or from below, try to get further into the small bowel. Or we would have to do more invasive x-ray studies involving catheterization of larger vessels in the groin. Or we would consult our surgical colleagues and join them in the operating rooms and they would perform a procedure in which they would have a small incision in the small bowel where we could insert our scoped directly into the intestines and be able to look through the intestine directly.
So this is definitely a big step.
Dr. Mahajan: Correct, much less invasive.
So basically tell us what a patient would do, they come in and they - If you can't determine a condition this is what you go to? Or this is something you'll do on a regular basis no matter what?
Dr. Mahajan: This is typically a study that is often times authorized by insurance companies after more standard techniques have been utilized. So following other studies such as upper and lower endoscopy, if we can't define what the patient's problem is or bleeding source, we will then turn to video capsule endoscopy. From a patient perspective it involves a fasting over night, typically we have them eat or drink a light meal, finishing it by at least 4 o'clock the day before - clear liquids after that; fasting for approximately 6 to 8 hours as far as no liquids over night. They come into the clinic and they take the PillCam, they swallow it with 6 to 8 oz. of water, and they are connected to a data recording device and the PillCam sends images - two per second - to this data recording device, resulting in approximately 55 to 58-thousand images over an approximate 8 hour time frame. Patients are able to drink something clear approximately 2 hours after they start the study and 4 hours after they've ingested the PillCam they can have a light lunch.
That's definitely better than having to go through a surgery or some kind of procedure where you can be laid up for a while.
Dr. Mahajan: Correct. Correct. Patients can actually go to school, they can go back home, many patients take the opportunity to tour the city, to walk around - we encourage people to walk. If they go home and they take a nap or they lay down, the PillCam may not exit their stomach and give us the complete picture of the small bowel that we hoped for.
So they just come in, take the pill, and then does it just exit the way you would think it would go? It is disposable, not reusable?
Dr. Mahajan: Correct, that's a very good question. This is a disposable camera; we do not want the camera back. So we encourage people to look at their bowel movements for the PillCam. If the PillCam is not directly visualized exiting in the stool and if it is an incomplete study, meaning during the study we did not see it go into the colon, then we have to later evaluate the patient for possible PillCam retention. So what that means is the PillCam - the biggest side effect, is that it can become lodged in the small intestine. Very rarely, fewer than 5 percent of the time, the patient would require treatment for that, possibly even surgery. But as long as the patient sees the camera in the stool, we don't need any other follow up. If they don't see it, we typically get an x-ray one week later or have them come in earlier if they have any symptoms of a GI obstruction such as nausea or vomiting or any abdominal pain.
So the images are transferred to what, how does that work?
Dr. Mahajan: Oh, correct. So the patient during the study wears a data recording device, it's a small device, about the size of the portable electronic handheld games that children play today. They wear it on a belt or on a shoulder strap, and at the end of the study this data recording device is brought back to our clinic. It is then inserted into a downloading device, and an approximate 8 hour DVD is then burned for the physician to view.
And what do you do, what's the next step for you, a long day?
Dr. Mahajan: Uh, yes. When people ask me what I do after 8 o'clock at night, that's what I say. I view DVDs of peoples' small intestines. So, yea it takes sometimes several hours to actually read it. We're able to read it in fast view mode, which can sometimes give us the answer very quickly. But if we don't see anything on a rapid view, we need to sit down and review each of those individual pictures to make sure that we haven't missed any pathology because the disease process may be located on just one or two frames of that study.
So, talk about what this could mean for patients. We talked about how many people who may not have known what they had and this is pretty much the only way right?
Dr. Mahajan: Correct. It's been an absolute wonderful technology, its being increasingly utilized. Community doctors are learning more about it and referring patients in, or performing it themselves. For patients, it's enabled us to make diagnoses where as we couldn't before, we had no way of directly looking at the small intestine. So it has given us an opportunity to make numerous diagnoses of Crohn's disease, or find the bleeding source on patients where other tests have failed.
You said insurance covers this, correct?
Dr. Mahajan: Insurance typically covers this, yes.
Where do you see it going from here? Do you see more improvements coming, maybe ways that you can maneuver it yourself?
Dr. Mahajan: Very good question. Ya, so the future - here, the training program we run, we tell fellows - the trainees we have - that they need to grasp this technology and learn it because it is the way of the future. It may eventually replace our standard upper and lower endoscopies where we take very long scopes, that require the patient to be under sedation, and evaluate the upper and lower gastrointestinal tract. The movement currently is, they have already developed esophageal cameras to look at patients for esophageal varices or liver related complications of the esophagus. The colon is now being studied with colonic PillCams and they are looking at radio controlled or robotic devices, where we'll actually someday be able to possibly maneuver these capsules back and forth in the intestines and not only use them for diagnostic purpose but also therapy. So there may be an option in the future for removing polyps or treating bleeding lesions.
Like a Sci-Fi Movie.
Dr. Mahajan: I know. I can't wait, someday my career will be a video game career.
I got in the wrong field.
Dr. Mahajan: I know. So when my kids ask, I say I play video games at work. They're jealous.
Alright, anything else you want to add that we didn't hit on?
Dr. Mahajan: Um, I think you covered most of it; complications - I think we talked about.
Up until the start of this conversation, I was assuming that the capsule had to be retrieved and all the information was recorded inside that capsule, but…
Dr. Mahajan: The data recorder.
Right, so could you just reiterate that fact, just that the capsule, once it's swallowed we don't have to see all the information.
Dr. Mahajan: So the capsule, once swallowed, literally sends or beams images to the data recording device worn by the patient. The PillCam does not need to be retrieved; it is typically passed in a bowel movement and flushed into the toilet. There are no reports of plumbing problems related to that, and all the data that we need is in the data recorder device that the patient brings back to the clinic at the end of the day. And we have um, some contraindications. So, the big thing in pediatrics is that it's not small. So there's one size PillCam for all, so we have also - I think we have the only study in literature - of the use of a deployment device. So I can take this thing on the end of a scope, and shoot it past the stomach, into the small bowel of little kids. Here at the Cleveland Clinic, we've done over 350 of these studies. The youngest patient we've done here is 3 years old, but in other centers around the world, they have been done in children under 1 year of age to evaluate bleeding.
With using that device to get through…?
Dr. Mahajan: Correct. So if a patient - so contraindications are patients that we can not use this technology in, or anyone that we think has a narrowed area somewhere in the small bowel where it will become lodged. Or in patients who are unable to swallow it. So, the way around the swallowing issue is that we can attach a device to the end of our scope, a deployment device, and take the PillCam down through the esophagus, through the stomach, into the small bowel and deploy it into the small intestines. So even though a patient can't swallow it possibly, we can still utilize the technology.
And like you said, it's got to help when you're trying to treat someone under one year old to be able to do it that way.
Dr. Mahajan: Correct.
FOR MORE INFORMATION, PLEASE CONTACT:
Tora Vinci
Media Relations
Cleveland Clinic
(216)444 -2412
vinciv@ccf.org
