**3. New features of colon capsule 2**

The shortcomings of this first colon capsule were analyzed and the capsule underwent a thorough overhaul. The second generation colon capsule has the following improvements. The angle of view of this new colon capsule camera was extended from 154 to 172 degrees for each camera. This change provides a near full panorama view (see Figure 2).

**d.** and finally notifies that the patient may eat and that the procedure is over.

ing through the transverse colon.

This is how the second generation colon capsule system works. Three minutes after swal‐ lowing the capsule the rate of transmission is reduced to 16 images per minute to conserve energy. The received images are constantly analyzed by DR3. If after one hour DR3 notices that the colon capsule has not left the stomach it will instruct the subject by ringing an alarm tone and activating a vibrating device attached to the antenna to look at the LCD screen where the digit 0 is displayed. The patient's instruction sheet indicates that the appearance of digit 0 requires the subject to take a prokinetic agent such domperidone or metoclopra‐ mide. However if the capsule has left the stomach and entered the small bowel, the smart features of DR3 recognize that the capsule is now in the small bowel. DR3 orders the capsule to raise its transmission rate from 16 images per minute to 4 images per second and the pa‐ tient to ingest the booster laxative. The purpose of this booster laxative is to shorten small bowel transit time of the colon capsule and to maintain adequate cleanliness of the bowel. Furthermore, all incoming images from the colon capsule are analyzed online by this "intel‐ ligent" DR3 that recognizes if the capsule is stationary or in motion. Once DR3 recognizes that the capsule is in motion it orders the capsule to raise its transmission rate of images to a staggering 35 frames per second. As mentioned, the process of recognition to execution takes place in a fraction of a second. This rapid transmission rate (35 frames per second) pro‐ vides adequate number of colonic images while the capsule is in motion especially while fly‐

Colon Capsule Endoscopy: Quo Vadis? http://dx.doi.org/10.5772/53055 247

Polyp size is of course clinically very relevant. The larger the size of a polyp the greater the chances that the polyp has advanced neoplastic changes. The software program for colon capsule 2 is equipped with a polyp size assessor. The cursor is drawn from one side of the polyp to the other and the algorithm spits out the size of the polyp in mm. The same polyp

These technological achievements are very impressive (a data recorder communicating with capsule and patient, a data recorder that analyzes images, determines location, position –sta‐ tionary versus motion, and accordingly alters transmission rate of frames per second by the

We engaged in a five center prospective double blind feasibility study in Israel in which this second generation colon capsule was compared to standard colonoscopy for the identifica‐ tion of patients with colonic polyps. 104 patients were enrolled. Whereas in the European multicenter trial published in 2009 the sensitivity to identify patients with polyps was only 58% the sensitivity in the multicenter Israel trial with the second generation colon capsule rose to 89% [5]. This marked improved diagnostic sensitivity was reproduced by a recent European study with the second generation colon capsule [6]. This improvement (raise in diagnostic sensitivity from 58% to 89%) has to be attributed to the revolutionary new capsu‐ le platform of this second generation colon capsule for the following reasons. Firstly, the

seen from distance or from close up will have the same size measurement.

capsule). Yet the gnawing question remains. Is this device medically relevant?

**4. Results of clinical trials with colon capsule 2**

**Figure 2.** The left side image demonstrates the angle of view of the out dated C1 colon capsule. The right hand image demonstrates the angle of view of the C2 colon capsule with a near panoramic view.

The Data Recorder 3 (DR3), the device that collects the transmitted digital information from the capsule, is a true revolution in capsule endoscopy. Smart features have been imbedded in this device. Bidirectional communication between capsule and DR3 takes place. The DR3 receives information from the capsule and accordingly directs the capsule with correspond‐ ing instructions. The capsule receives online orders by the DR3. The capsule transmits its images at four images per second when in stationary condition. When DR3 recognizes that the incoming images indicate that the capsule is in motion it orders the capsule to raise the transmission rate to 35 images per second. This entire circle of receiving optical information from the capsule, online analysis by the DR3 and execution of the DR3 orders by the capsule takes place within a split second. Furthermore, DR3 also communicates with the patient un‐ dergoing the colon capsule examination and instructs the patient if and when to take a pro‐ kinetic agent, which shortens gastric transit time and moves the capsule more expediently form stomach into small bowel. The DR3 notifies the patient


**d.** and finally notifies that the patient may eat and that the procedure is over.

The angle of view of this new colon capsule camera was extended from 154 to 172 degrees

**Figure 2.** The left side image demonstrates the angle of view of the out dated C1 colon capsule. The right hand image

The Data Recorder 3 (DR3), the device that collects the transmitted digital information from the capsule, is a true revolution in capsule endoscopy. Smart features have been imbedded in this device. Bidirectional communication between capsule and DR3 takes place. The DR3 receives information from the capsule and accordingly directs the capsule with correspond‐ ing instructions. The capsule receives online orders by the DR3. The capsule transmits its images at four images per second when in stationary condition. When DR3 recognizes that the incoming images indicate that the capsule is in motion it orders the capsule to raise the transmission rate to 35 images per second. This entire circle of receiving optical information from the capsule, online analysis by the DR3 and execution of the DR3 orders by the capsule takes place within a split second. Furthermore, DR3 also communicates with the patient un‐ dergoing the colon capsule examination and instructs the patient if and when to take a pro‐ kinetic agent, which shortens gastric transit time and moves the capsule more expediently

**a.** when to ingest the first booster laxative which accelerates small bowel transit time of

for each camera. This change provides a near full panorama view (see Figure 2).

246 Colonoscopy and Colorectal Cancer Screening - Future Directions

**C C2** <sup>172</sup> **1** <sup>154</sup> <sup>0</sup> <sup>0</sup>

demonstrates the angle of view of the C2 colon capsule with a near panoramic view.

form stomach into small bowel. The DR3 notifies the patient

the capsule and keeps the colon clean,

**b.** if and when to ingest a second booster laxative

**c.** if and when to insert a bisacodyl suppository

This is how the second generation colon capsule system works. Three minutes after swal‐ lowing the capsule the rate of transmission is reduced to 16 images per minute to conserve energy. The received images are constantly analyzed by DR3. If after one hour DR3 notices that the colon capsule has not left the stomach it will instruct the subject by ringing an alarm tone and activating a vibrating device attached to the antenna to look at the LCD screen where the digit 0 is displayed. The patient's instruction sheet indicates that the appearance of digit 0 requires the subject to take a prokinetic agent such domperidone or metoclopra‐ mide. However if the capsule has left the stomach and entered the small bowel, the smart features of DR3 recognize that the capsule is now in the small bowel. DR3 orders the capsule to raise its transmission rate from 16 images per minute to 4 images per second and the pa‐ tient to ingest the booster laxative. The purpose of this booster laxative is to shorten small bowel transit time of the colon capsule and to maintain adequate cleanliness of the bowel. Furthermore, all incoming images from the colon capsule are analyzed online by this "intel‐ ligent" DR3 that recognizes if the capsule is stationary or in motion. Once DR3 recognizes that the capsule is in motion it orders the capsule to raise its transmission rate of images to a staggering 35 frames per second. As mentioned, the process of recognition to execution takes place in a fraction of a second. This rapid transmission rate (35 frames per second) pro‐ vides adequate number of colonic images while the capsule is in motion especially while fly‐ ing through the transverse colon.

Polyp size is of course clinically very relevant. The larger the size of a polyp the greater the chances that the polyp has advanced neoplastic changes. The software program for colon capsule 2 is equipped with a polyp size assessor. The cursor is drawn from one side of the polyp to the other and the algorithm spits out the size of the polyp in mm. The same polyp seen from distance or from close up will have the same size measurement.

These technological achievements are very impressive (a data recorder communicating with capsule and patient, a data recorder that analyzes images, determines location, position –sta‐ tionary versus motion, and accordingly alters transmission rate of frames per second by the capsule). Yet the gnawing question remains. Is this device medically relevant?
