Biomedical Engineering Reference
In-Depth Information
upright. The PillCam TM ESO travels through the esophagus by normal peristaltic
waves, capturing 14 images per second. The images are transmitted to three sensor
arrays placed on the patient's chest and connected to a data recorder. The pill is
later excreted naturally after dropping into the stomach. It takes 20 minutes to
complete the procedure and 2,600 color images are acquired. Then the physician
views and assesses the results just like using PillCam TM SB.
The first clinical trial on PillCam TM ESO concerned gastroesophageal reflux
disease (GERD) (Eliakim et al. 2004), which may develop Barrett's esophagus and
in turn lead to esophageal adenocarcinoma. In 2007, PillCam TM ESO 2 gained FDA
approval and was put into clinical use. The improvements of the new capsule are
similar to PillCam TM SB 2, which include: increased capture rate of 18 frames per
second, better image quality, wider angle of view and additional Automatic Light
Control (ALC) to provide optimal illumination for each image.
13.2.1.3 PillCam TM Colon
The PillCam TM Colon capsule measures 11 mm
31 mm. It has one micro camera
at each end which captures 4 images a second for up to 10 hours. The platform
for PillCam TM COLON includes the same components as PillCam TM SB, i.e., a
sensorarray,adatarecorderanda RAPID TM workstation. But the procedure
is different in two aspects. One is that a prep, as well as additional prokinetic
agents to enhance capsule propulsion, are needed beforehand. Besides, the capsule
takes pictures for three minutes after being swallowed, providing images of the
esophagus and stomach. Then it turns itself off for 105 minutes to preserve the
battery while it passes through most of the small intestine on its way to the large
bowel.
PillCam TM COLON has received European CE Mark in 2006 and a medical
device licence from Health Canada in 2007, but was rejected by FDA in 2008
for commercial distribution in the USA. The company claimed that they were
accelerating development of a next generation colon capsule.
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13.2.1.4 Agile TM Patency System
Capsule retention has been an area of significant controversy and concern amongst
capsule users. As defined by 2005 International Conference on Capsule En-
doscopy, this complication means the capsule remaining in the GI tract for at
least two weeks and needing surgical, endoscopic or medical therapy to help to
extract. The frequency of capsule retention depends on the clinical indication
for capsule endoscopy, ranging from 0% in healthy subjects, 6.7% in patients
with Crohn's disease (Buchman et al. 2004) and as high as 21% in patients with
intestinal obstruction (Pennazio 2006). The overall incidence is about 1
2%. It
also represents a risk for the patients with a history of dysphagia, i.e. a difficulty
to swallow, while undergoing esophageal capsule endoscopy. Therefore, Given
Imaging has put forward the Agile TM Patency System (Spada et al. 2005) as an
accessory to the PillCam TM video capsule, which was approved by FDA in 2006.
The device is an 11mm
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26mm ingestible and dissolvable capsule made of
 
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