New Test Using Swallowed Camera?
Posted 03 February 2005 - 06:00 PM
Met with Dr. A. Fasano in Baltimore (Dec 2006), who felt I didn't need to be tested based on my history and positive response to the gluten-free diet.
Posted 03 February 2005 - 07:42 PM
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
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August 1, 2001 Consumer Inquiries: 888-INFO-FDA
FDA CLEARS CAMERA PILL TO PHOTOGRAPH SMALL INTESTINE
FDA today cleared for marketing a swallowable capsule containing a tiny camera that snaps pictures twice a second as it glides through the small intestine.
The product represents a technological advance in methods of examining the gastrointestinal tract.
The device, made by Given Imaging Ltd., an Israeli company with North American headquarters in Norcross, Ga., is intended to visualize the inside of the small intestine to detect polyps, cancer, or causes of bleeding and anemia.
Currently the standard method of detecting abnormalities in the intestines is through endoscopic examination in which doctors advance a scope down into the small intestine via the mouth. However, these scopes are unable to reach through all of the 20-foot-long small intestine, and thus provide only a partial view of that part of the bowel.
The camera capsule is designed to take photos of the entire small intestine, enabling doctors to see areas that the endoscope cannot reach.
The device, called the Given Diagnostic Imaging System, comes in capsule form and contains a camera, lights, transmitter and batteries. The capsule has a clear end that allows the camera to view the lining of the small intestine.
The patient swallows the capsule, and the natural muscular waves of the digestive tract propel it forward through the stomach, into the small intestine, through the large intestine, and then out in the stool. The capsule transmits the images to a data recorder, which is worn on a belt around the patient's waist. The physician then transfers the stored data to a computer for processing and analysis.
The battery has an expected life of eight hours, which is generally long enough to photograph the small intestine, but not long enough to photograph the entire gastrointestinal tract.
FDA cleared the device based on both animal and clinical studies of safety and effectiveness conducted by the manufacturer. In one of the human trials, Given Imaging studied the use of the camera capsule in patients with suspected small intestine disease. All patients had signs of either unexplained chronic gastrointestinal blood loss or anemia. All had undergone standard endoscopic and radiological evaluations prior to receiving the capsule.
Study results showed that the camera pill was safe, without any side effects, and was able to detect abnormalities in the small intestine, including parts that cannot be reached by the endoscope.
FDA cleared the device for use along with--not as a replacement for--other endoscopic and radiological evaluations of the small bowel. The capsule was not studied in the large intestine.
The product is available by prescription only.
I have read where the test costs about 1200 dollars. I'm not sure how that compares to a traditional scope.
Here is a link to an article in which a photo of the device is shown http://www.detnews.c.../a08-337857.htm
Here is the text:
Camera pill takes doctors inside the digestive tract
Device helps diagnose intestinal problems that were a mystery before
By Patrick Condon / Associated Press
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DES MOINES, Iowa -- Doctors have used small cameras on snaking tubes for years to check patients' intestinal troubles. These days, they're asking some patients to swallow the entire camera.
With a single pill loaded with technology similar to a digital camera, doctors can view more than 50,000 still images captured during the trip through the final 20 feet of the small intestine that previously was visible only on X-rays.
The pill, known as the M2A Capsule Endoscopy, is about the size of a multivitamin and is swallowed with a sip of water.
The camera, encased in a white plastic capsule, takes pictures, which are transmitted on a radio frequency. The images are captured in a recording device worn on a belt around the patient's waist. After eight hours, the belt is turned over to the doctor.
The device is a "marvel of microelectronics," said Dr. David Ramkumar, a gastroenterologist at the University of Iowa Hospitals and Clinics, where patients since the beginning of the year have been swallowing the capsules to diagnose intestinal problems.
Hospitals and clinics around the country, in increasing numbers, have been using the technology since the Food and Drug Administration approved it in December 2001.
Seventy-one-year-old Ruth Brown wanted to know why she was suffering from persistent intestinal bleeding. Her doctors had probed her stomach and performed a colonoscopy, but were stumped.
They suggested the camera pill.
"I looked at it and said, 'Oh, doctor, I can't swallow that,' " Brown said. "A great big horse pill -- that's what it looked like."
Despite her worries, she swallowed it with a mouthful of ice water.
Patients fast for 10 hours before taking the pill, and are able to go about their days as long as they avoid strenuous activity. Brown was able to work her regular volunteer shift at a hospital.
For years, doctors used cameras on elongated flexible tubes to examine the upper portions of the digestive system and the colon. About 20 feet of the small intestine could not be reached with the endoscope so doctors would have patients swallow barium, then X-ray the area to look for trouble spots -- a test Ramkumar called unreliable.
Invasive surgery would be the next option if a disorder was diagnosed.
The tiny camera "provides a view of that middle portion of the digestive tract that we have not had previously," Ramkumar said.
The camera pill has been an effective way to diagnose unexplained bleeding, Crohn's disease, celiac disease and intestinal tumors. Ramkumar said the pill has been successful on patients who, like Brown, show clear evidence of intestinal bleeding, but in whose cases conventional tests have not turned up a cause.
Using the images retrieved by the camera, Ramkumar determined that Brown's persistent bleeding was caused by radiation burns in her small intestine left over from cancer treatment seven years earlier, and exacerbated by a prescription blood thinner.
"They've taken me off the blood thinner," Brown said, and since then her bleeding has been much less. Brown said the burns are so spotty that doctors decided it would be impossible to cut them all out, but the steps taken since the diagnosis have improved her health immeasurably.
Doctors at the University of Iowa Hospitals and Clinics expect to treat more than 150 patients with the camera pill by the end of the year, spokesman Tom Moore said.
The procedure costs about $1,200 at the hospital in Iowa City. Ramkumar said the pills are purchased directly from the manufacturer, Israel-based Given Imaging, for $450 each, a price included in the cost of the procedure.
At the University of Iowa Hospitals and Clinics, results so far have shown a 60 percent to 70 percent success rate in detecting abnormalities. That may seem low, but it is considerably better than old methods of detection, Ramkumar said.
The pill isn't 100 percent successful because, due to its small size, the camera can capture an image of only about 70 percent of the digestive tract at any one point, he said.
Still, "If you compare that with what we had before, we were looking at rates optimistically in the 30 to 40 percent range," Ramkumar said. "We're practically doubling our success."
Once the images are recorded and the camera belt is removed, the patient simply passes the pill.
"They aren't used again," Moore said.
Gluten Free since 12-31-2002!!
Posted 03 February 2005 - 08:39 PM
Been having anemia (low iron) for quite some time. Docs were convinced that I was bleeding somewhere, which was lowering my iron stores. Swallowed the camera in December after already doing all kinds of other fun tests - small bowel follow through, endoscopy, gastroscopy, etc. The pictures lead the doctor to do a blood test for antibodies indicating Celiac, and they came back positive! Way positive!
Been on a gluten-free diet for 5 weeks now and just had a blood test this week to check my iron. It's almost back into the normal range! We'll do another antibody test in a few months to see where that's at.
The camera does work. The harness that you have to wear for the 8-hour test is the worst part - pretty uncomfortable. There is a small chance (about 1%, I think) of the camera getting stuck, causing a bowel obstruction. I had no problem.
Cost was about $1300.
Any more question - I'll try to help!
Klamath Falls, OR
Posted 03 February 2005 - 09:04 PM
Did your insurance company pay for the camera pill??
And did you need an intestinal biopsy afterwards to confirm the celiac diagnoses??
Posted 05 February 2005 - 08:44 AM
Insurance picked up almost all of the bill, except for my co-pay amount. The doctor's office checked with them first, just to make sure.
We didn't do a biopsy. Doctor felt that what he saw from the camera, along with the very positive blood test, was good enough.
Not sure I agreed with him on that, but the gluten-free diet seems to be working. I didn't present with all the classic sysptoms many CDers have - severe diarrhea, cramping,etc. The anemia was really my only symptom, and it is definitely improved.
Hope that helps!
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