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

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 three previous studies with the first generation colon capsule had a very similar design as the present studies with colon capsule 2 and are thus comparable. Secondly, good bowel cleansing is a determining factor for a successful study. Good bowel cleansing was obtained at similar rates in the studies with colon capsule 1 as in the new studies with colon capsule 2. Thirdly, capsule exrection of a capsule still transmitting images is a prerequisite for a suc‐ cessful colon capsule study. Capsule excretion rates of the studies with colon capsule 1 and the studies with colon capsule 2 were the same. The only factor which set this second gener‐ ation colon capsule study apart from the previous studies is the new technological platform. It is for this reason that we credit the improvement in technology for the improved diagnos‐ tic sensitivity of 30%.

equal uptake (adherence to participate in colon cancer screening) was assumed, it became an efficient option when it was assumed that uptake of CCE would be higher than that of

Colon Capsule Endoscopy: Quo Vadis? http://dx.doi.org/10.5772/53055 249

**•** "CCE is a feasible and safe tool for visualization of the colonic mucosa in patients with

**•** "Small-bowel capsule endoscopy provides a very high diagnostic yield for small-bowel mucosal lesions and its use is recommended in specific scenarios of IBD (Inflammatory Bowel Disease). Similarly, CCE could be used to identify mucosal changes in the colorec‐

We will dwell on two mentioned issues raised in the European Guidelines, namely the use of capsule colonoscopy in screening for colonic polyps and the use of capsule endoscopy in

**6. Can colon capsule endoscopy play a role in clinical medicine today?**

**a.** Screening patients for presence of colonic polyps as primary colon cancer prevention.

Colonoscopy is the accepted gold standard and the most sensitive method to investigate pa‐ tients for the presence of colonic polyps. While colon cancer screening programs are availa‐ ble the participation rate of the general population has been disappointingly low. The reasons for the low adherence rate are multifactorial. Colonoscopy is associated with dis‐ comfort/pain, so there is a need for sedation, there are complications, albeit small, the proce‐ dure leads to loss of work and there is the issue of the invasion of one's privacy. Recently it has been reported that post procedural pain necessitating visits to the emergency room fol‐ lowing colonoscopy has been underestimated. While these reservations may appear trivial to gastroenterologists, this is perceived differently in the general public. Inadomi et al pub‐ lished the results of a prospective randomized trial [9]. In the office setting eligible patients were offered either colonoscopy or fecal occult blood testing (FOBT). 12 months thereafter 38% of patients offered colonoscopy had completed the procedure, while 31% more, a total

They concluded that our common practice of universally recommending only colonoscopy

In a prospective study performed in Germany to examine whether colon capsule endoscopy could increase adherence to screening colonoscopy in a healthy population Groth et al found that offering capsule endoscopy led to a fourfold increase of screening uptake com‐

Rex and Lieberman published a survey study that colon capsule endoscopy could raise col‐ orectal cancer screening adherence rates among patients who decline screening colonosco‐ py. This was especially apparent when the participants in this survey were offered colon capsule endoscopy as an out of clinic test with no loss of work. We published a cohort study

colonoscopy for CRC screening, a premise that has not been demonstrated yet."

incomplete colonoscopy and without stenosis."

of 69% of patients offered FOBT had done the test.

pared to standard colonoscopy [10].

may actually reduce adherence to colorectal cancer screening.

tal mucosa. …"

incomplete colonoscopy.

Colon capsule 2's negative predictive value of 97% is very high and is clinically very mean‐ ingful. The physician discussing the results of a negative colon capsule 2 study with his pa‐ tient can reassure her/him that that a negative colon capsule 2 study has a 97% accuracy that there are no polyps.

The fact that the smart features of DR3 enable communication with the patient has opened the door to offer colon capsule examination as an out of clinic procedure [7].
