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FDA approves PillCam video camera that you swallow

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February 6, 2014

The PillCam Colon has been approved for us in the US by the FDA

The PillCam Colon has been approved for us in the US by the FDA

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Colonoscopies can be an uncomfortable procedure for patients who may already be worried about what results will be found. When the results are inconclusive, a patient's options can be limited, causing further distress. The US Food and Drug Administration (FDA) has now approved a device for use after an incomplete procedure that is minimally invasive and can achieve similar imaging results to a colonoscopy. PillCam Colon is a pill-sized camera that is swallowed and passes through a patient's gastrointestinal tract.

Given Imaging's PillCam Colon was created specifically with the purpose of checking for colon cancer and is already commercially available in more than 80 countries. The study on which the FDA based its decision focused on identifying hyperplastic polyps and adenomas at least 6 mm in size. It found a 69 percent positive agreement between PillCam Colon results and a colonoscopy, and an 81 percent negative agreement.

A colonoscopy is the examination of a patient's bowel using a long, thin camera known as an endoscope that is inserted via the rectum. Around 750,000 incomplete colonoscopies occur each year in the US, and are more common in women due to higher incidences of previous pelvic surgery and anatomical challenges for navigation. An incomplete colonoscopy often requires that a patient undergoes an additional procedure, such as an X-ray or CT scan, in order to complete the colorectal examination, incurring extra costs and risks in the process.

the PillCam Colon is a pill-sized video camera that patients swallow and passes through th...

The device itself is a pill-sized video camera measuring 12 x 33 mm (0.47 x 1.3 in) that captures color video from both of its ends at 4 or 35 frames per second. An LED provides the necessary illumination for image capture and, once swallowed by the patient, it wirelessly relays footage to a recording device worn by the patient for approximately 10 hours.

"We have made tremendous strides in increasing the number of people who are getting screened for colon cancer, starting at age 50 for the average risk individual," says Eric Hargis, CEO of US patient advocacy and support organization Colon Cancer Alliance. "Colonoscopy is the most comprehensive option, but for up to 10 percent of individuals, achieving a complete colonoscopy may not be possible. For those individuals, PillCam Colon capsule endoscopy could be an effective option to allow their gastroenterologist to complete a colon examination."

The video below shows PillCam's journey through the body.

Source: Given Imaging

About the Author
Stu Robarts Stu is a tech writer based in Liverpool, UK. He has previously worked on global digital estate management at Amaze and headed up digital strategy for FACT (Foundation for Art and Creative Technology). He likes cups of tea, bacon sandwiches and RSS feeds.   All articles by Stu Robarts
13 Comments

So...You can now swallow this AFTER you have had the invasive colonoskopy already done, assuming that it came back inconclusive.

So much for having an invasive colon check up....

Thankfully I've never had one, and by the look of technology, by the time I will need a check up (over a decade) non-invasive will be the norm. That's assuming the FDA gets off their asses and actually approves some of the medical breakthroughs that happen on a nearly daily basis.

Derek Howe
6th February, 2014 @ 08:29 am PST

Uh, this "pill" is 1.3 inches long! How the hell am I supposed to swallow a pill that huge???

Also, how exactly am I supposed to retrieve this lovely little rosebud once it has passed through my system? Do I need to put a strainer over my toilet and sort through the muck to get it back to my doctor?

This needs to be smaller and disposable.

Dax Wagner
6th February, 2014 @ 11:06 am PST

As the other two comments have noted, swallowing it after you've had the dangerous colonoscopy, and its large size, make it a very worthless 'advancement'.

And when you read the fine print at the end of the video, they don't even guarantee to see/detect any/all cancerous growths.

This is rubbish and a waste of talent and time.

Someone get onto this and address the above concerns and you'll make a fortune.

AustraliaHouses
6th February, 2014 @ 04:52 pm PST

Two problems -

1: As mentioned it is relatively huge and hard to swallow.

2: Does it come with little "windscreen wipers" in case it encounters anything a little more 'clingy'?

And it does not replace the now available procedure anyway!

The Skud
6th February, 2014 @ 07:15 pm PST

The approval is significant and so is the devise. You have to have a proven market and advantage before anyone will ever spend more money on researching these devises. If you ever want to see one of these become smaller and cost less you have to start selling one and return a profit. Only then will people advance the device to become smaller and cheaper. Also once a devise is approved alterations to the original device (such as size) are easier to get approved with the FDA. I have been waiting to see one of these devises get approved for a while because I plan to die before ever having a colonoscopy unless it's with a really cute female doctor or nurse. Now I don't have to have a colonoscopy I can just swallow a pill. However, I don't think anyone wants to swallow a reused pill (do you know where that's been) but if you sterilize it, rewrap and open infront of the patient most people won't even think of where it's been, they'll just think it's new.

Matt Fletcher
7th February, 2014 @ 07:16 am PST

The device does represent an improvement over the current process in that the patient does not have to go to the hospital or be sedated.

All joking about "roadblocks" for the pillcam aside, patients would still undergo the normal pre-treatment where they take medication in combination with a large amount of fluid (typically Gatorade) to empty the bowels thus clearing any traffic from the gastro-intestinal highway.

Today it's approved for use in secondary procedures. In a few years the technology will have improved enough that it will likely become the primary diagnostic tool.

AllenH
7th February, 2014 @ 08:22 am PST

I've had a colonoscopy with one of these devices several years ago at the Mayo Clinic. At that time, the device was the M2A (Mouth-to-Anus) which provided photos, but no video. So this new version should be quite a measurable improvement.

The pill I swallowed was large, and required some additional steps because of a restriction I had in my esophagus, but eventually, it went down.

The M2A had four LED's, and the data was transmitted from the pill to a recorder which I wore in a pouch on my chest.

The primary difficulty with the pill camera comes with interpreting the pictures, because the radiologist who reads the data must try to determine where in the bowel the anomolies are situated.

As for retrieval, one can attempt this and place the pill camera on the mantle over the fireplace, where it will be a wonderful souvenir of the trip. However, as a practical matter, the pill camera is not recovered owing to the fact that it would have to be refurbished with a new battery, and there would be some reluctance on the part of the next guy to swallow an item which was recently obtained so inelegantly.

Ralph L. Seifer, Long Beach, California

rseifer
7th February, 2014 @ 08:43 am PST

Fine for the first user but do ya want to be the next in line to reuse it?

donwine
7th February, 2014 @ 09:17 am PST

Firstly, that M2A needs a rename. I thought you were kidding.

But since many of the commentors claim never to have had a colonoscopy: good for you, but this thing will be a godsend to those of us who have had several... 1. The hospital time for a colonoscopy in TX is about $10,000. 2. The other fees add up to $5000 or more. 3. The wait time for scheduling can be weeks, so hopefully you won't be in pain when you need it. 4. It could be embarassing, especially the first time. 5. The mortality rate for anesthesia is over 1000 times higher than death on an airliner, so it's not as safe as a plane trip...So compared to a $20,000 price tag, I think they will be able to afford to make them disposable. But you probably shouldn't flush something like that down the toilet, so they could send you home with a tropical fish net or something...all in all, these puny concerns far outweigh the benefits..

DallasDave
7th February, 2014 @ 10:08 am PST

I must be missing something.The PilCam is not new. I used one of these devices about two years ago as part of my "regular" colonoscopy. I can address several of the questions/comment. The "pill" is large and some folks cannot swallow it. However, with adequate water I had little trouble doing so. As far as retrieval - fergeddaboutit! I looked for the little bugger at the other end and never did retrieve it. It is considered a disposable item. Although, I did find some used ones offered for sale on eBay! They are not meant to be reused. The images (one every few seconds) are captured on an externally worn RF receiver and processed after the fact. One advantage of this device is that is records the entire GI tract, from one end to the other. Please note, I am not a physician nor do I play one in the movies or on TV.

SteveJobsSon
7th February, 2014 @ 02:03 pm PST

Lets do the math.

750,000 incomplete.

10 percent incomplete rate.

7,500,000 colonoscopies a year in the USA.

USA pop 317 million.

Is this really necessary?

Buzz Allnight
7th February, 2014 @ 03:18 pm PST

The numbers certainly aren't as good as a colonoscopy, not even close. Fecal matter will block much of the shots even after fasting; a dirty lens will spoil the shots much of the way through. During a colonoscopy the colon is inflated and the doctor can stop and check stuff much smaller than six millimeters plus he/she can cut off any polyps they see on the spot.

maak
8th February, 2014 @ 04:42 pm PST

Having had too many endoscope procedures (upper and lower) to remember accurately wighout consulting my medical records - I have cancer and an idiopathic condition - I can tell you that while this is a great advancement for the technology itself, it is not a major leap for diagnosis and treatment.

The pillcam has actually been around and in use for about 14 years now. "FDA Approval" just means insurance reimbursement is more readily available.

The pillcam has lots of drawbacks - some of which have been commented upon - and is not viewed as a replacement for traditional endoscopy.

The main use of this device is in instances where the biology of a specific patient renders the traditional scopes inconclusive or not even viable. One particular instance is when the location of suspected tumors, etc. are out of the reach of the standard endoscope (e.g. where the large and small intestine connect at the ileum).

Joseph Boe
10th February, 2014 @ 01:53 pm PST
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