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Lisa

Mayo Study On Pillcam

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Given Imaging Announces New Mayo Clinic Study Concludes Celiac Disease May Be More Severe Than Symptoms Indicate for Some Patients

PillCam® SB Visualizes Disease Severity, Guides Treatment and Provides Better Sensitivity for the Detection of Villus Atrophy

March 03, 2008: 08:30 AM EST

Given Imaging Ltd. (NASDAQ: GIVN) today announced that a study by researchers at the Mayo Clinic reported that capsule endoscopy is a more effective tool to diagnose celiac disease and detect damage throughout the small intestine than upper endoscopy. Researchers also found that celiac affects a highly variable portion of the small intestine and that the severity of symptoms did not correlate to the severity of intestinal damage.

The Mayo study utilizing Given Imaging's PillCam SB was led by Mayo Clinic gastroenterologist Joseph Murray, M.D. and appears in this month's issue of Clinical Gastroenterology and Hepatology.

"We're pleased that this study confirms that PillCam SB, which has the advantage of visualizing the entire small bowel, can help clinicians diagnose and monitor the severity of celiac disease regardless of their patient's symptoms," said Homi Shamir, CEO of Given Imaging.

According to the Mayo Clinic, this study, which is the first of its kind, used capsule endoscopy to view intestinal damage in 38 patients with untreated, biopsy-proven celiac disease. Indications for clinical evaluation were malabsorption syndrome and iron deficiency anemia. Ninety-two percent had visible damage detected by capsule endoscopy while upper endoscopy only detected visible damage in 55% of the patients. Neither capsule endoscopy nor upper GI series yielded false positives.

This study also indicated that a high proportion of adults may not heal their intestinal abnormalities even after a year or more on a gluten-free diet. Biopsy specimens of the proximal small bowel alone may not reflect the healing that has occurred distally in response to a gluten-free diet. Capsule endoscopy showed that healing in the small intestine occurred from the distal to the proximal direction with most residual changes remaining in the duodenum. Capsule endoscopy may play a role in monitoring the healing process of a patient on a gluten-free diet.

Given Imaging's PillCam SB video capsule was the first capsule endoscope on the market designed specifically to help doctors see inside all 30-feet of the small bowel (small intestine) to diagnose disorders such as Crohn's disease, Celiac disease, benign and cancerous tumors, ulcerative colitis as well as others disorders.

The smooth plastic capsule contains a miniature video camera and is equipped with a light source on one end, batteries, a radio transmitter and antenna. After it is swallowed, the PillCam SB capsule transmits approximately 50,000 images over the course of an 8-hour period (about 2 images per second) to a data recording device attached to a belt worn around the patient's waist. The small bowel images are then downloaded into a Given


Lisa

Gluten Free - August 15, 2004

"Not all who wander are lost" - JRR Tolkien

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pretty incredible....

so my doctor wanted to do a capsule endoscopy in order to officially rule out my crohn's diagnosis from 14 years ago.... however, my insurance carrier (AETNA) denied it..... isn't that nice? they are still appealing it, but i think it would be valuable to see the extent of the damage that my untreated celiac had on my insides for so many years


Joe

Dx Crohn's Disease - December, 1993

Positive Blood Test - November, 2007

Positive Biopsy - December 21, 2007

Gluten Free since December 3, 2007

Crohn's Medication stopped on January 17, 2008

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Ninety-two percent had visible damage detected by capsule endoscopy while upper endoscopy only detected visible damage in 55% of the patients. Neither capsule endoscopy nor upper GI series yielded false positives.

This is HUGE!

Thanks for posting this, MG.

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Ninety-two percent had visible damage detected by capsule endoscopy while upper endoscopy only detected visible damage in 55% of the patients.

This is HUGE!

Thanks for posting this, MG.

That's the line that I immediately zeroed in on as well. It really is huge-- let's hope that this soon becomes the standard method!


-Sarah

--Son, Lucas, age 7. Gluten-free since May 2007

--Son, Ezra, age 5. Gluten-free 10/13/07. Bipolar tendencies, massively improved on gluten-free diet! He's also allergic to a jillion antibiotics.

--My mother has Celiac Disease, dx'ed by Positive Blood Tests and Biopsy. Diagnosed Sarcoidosis 6/08.

--Myself, Gluten-free since 8/07

Time heals all hurt of heart... but time must be won.

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Stupid question but this means it is possible to dx Celiac based on the way the insides look??? My ped gi said he thought my daughter had a patch of flattened villi but would wait on the biopsy of that area to say yea or nay. Since he was looking for Celiac, he could convince himself it was a damaged spot. Once the biopsy came back negative, he decided it was normal looking. So a camera could see all of the intestines and if a spot looked bad, one could say it was Celiac????? Am I making the right jump of reasoning there??? I do have pictures and you can see it looks different but they said looks aren't enough to give a dx of Celiac. So the pill camera would change that?? EVen so that is a huge difference of stats.

Just wondering if in practice this would really give way to more dx of celiac or just lead to more frustration. YOu look like you have damage spots but we can't get a biopsy so can't give you a dx. That would be irritating to say the least.

Thanks

Stacie

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I am very glad that the PillCam is finally getting press! I was diagnosed via PillCam back when it was new. My bloodwork and endoscopic biopsy were both negative so I was very thankful that my doctor wanted to try it. We're both computer nerds so it was more 'wow this is cool' but it turned out to be so much more than that. I don't think most people understand that there is a huge section of your intestines not seen by a colonoscopy and endoscopy.


---------------------------------

MP - celiac for 10 years

 

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. . Ninety-two percent had visible damage detected by capsule endoscopy while upper endoscopy only detected visible damage in 55% of the patients.

This is HUGE!

Thanks for posting this, MG.

That's the line that I immediately zeroed in on as well. It really is huge-- let's hope that this soon becomes the standard method!

This is REALLY something!!

I've had a problem since forEVER w/ SO many ppl (I suppose mostly those in the 55% :P ) making a big deal about an endoscopy being "The Gold Standard" for dx.

Such an exclusionary term. :bahface:

Most of us know of the problems/subjective nature in both the endoscopy's procedure & interpretation, but it's a bit of a relief to see such irrefutable data.


>>>>>>> tom <<<<<<<

Celiac 1st diagnosed as a toddler, in the 60s. Docs then, between bloodletting & leech-tending, said "he'll grow out of it" & I was back on gluten & mostly fine for 30yrs.

Gluten-free since 12-03

Dairy-free since 10-04

Soy-free since 5-07

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This sounds amazing, but does the Pillcam get any biopsies when it's in there? Or would the doctors need to do an endoscopy and get a biopsy if the Pillcam is negative? I'm just wondering because this seems like a much easier option to try to convince my sister to do, since she's very reluctant to do an endoscopy, and refuses to believe that her positive blood test means anything.

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My daughter just had this done. She has had two endoscopies/biopsies in the last three years. Her GI did this because the upper endoscopy is very invasive and the pill came is "COOL" non invasive for kids. My daughter is nine. She still has symptoms of gluten even on a gluten free diet. After the camera endoscopy he diagnosed her with refractory sprue and put her on Entocort. Her intestines were much more damaged then the upper could see. After one day on the medication her diarrhea went away after 9 years. The Camera can not take a biopsy although it does take 2 pictures a second for eight hours I imagine it is very detailed. You probably would have to have the upper endoscopy after if a biopsy is needed.


Jessica

Daughter

9/05 Diagnosed Hypothyroidism

2/16/05 Biopsy diagnosed Celiac

8/14/06 Diagnosed Addison's Disease also known as Adrenal Insufficiency

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This is absolutely fascinating! I really wish I could have done this a few years ago when I was still eating gluten. I had two endoscopy/small bowel biopsies done and they were negative. I'm 95% sure I have celiac diesease though from my genetic testing and enterolab results. I'm wondering if I could/should go get it done now to see if there is still damage or as a tool for measuring improvement? Hmmm, maybe a visit is in store with my GI doc.


Don't be afraid to reach for the moon. The worst that can happen is you'll miss and land among the stars.

Positive blood work

2 negative biopsies over 4 year period

Postive EnteroLab results

Lactose/Casein Intolerant

Gluten free since May 2006

Soy free since May 2007

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How much does this PillCam test cost and do you HAVE to have a specialist prescribe it? Can a consumer get one done on his own if you're willing to pay for it?

I would assume that your Doctor would refer you to a Gastro guy familiar with the proceedure. I bet it's rather pricey, too.


Lisa

Gluten Free - August 15, 2004

"Not all who wander are lost" - JRR Tolkien

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I had this procedure done at the Mayo Clinic by Dr Joseph Murry. (He's been my gastro Dr since 2005.) The pill showed some areas that are inflammed and some that are healed. (zero flattened villi though) Unfortunately the last 2 hours of the pillcam malfunctioned and he wasn't able to see the last of the intestine. I am heading back to Mayo in May due to unexplained bleeding and low abd pain along with fatty liver. He's fearful that something was missed in that last 2 hours and wants to retest. Should be interesting. I'm one of those people who doesn't seem to be getting any better with the gluten free diet. He feels the continued malabsorption and pain is due to the liver problems.

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