PillCam® COLON Capsule
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
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New PillCam Design
2-sided video cameras; 4 images per second, 2 fps
per camera
Dimensions:
• Diameter: Same as PillCam SB
• Length: 5mm longer than PCSB
Optimized optics and automatic light control,
with each camera providing more than double
the area coverage of PillCam SB
~10 hours operating time
Ø11 mm

31 mm
PillCam® COLON Capsule
Sleep Mode
 Capsule shuts off 3 minutes post activation to preserve battery energy
 Capsule automatically turns back on after 1:45 hours before it enters
the colon
 European clinical trials with PillCam COLON have been using capsule
with 1:45 hours delay mode and Domperidone (e.g. Motililum®)
®
DataRecorder and RAPID
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SensorArray 8

10GB DataRecorder
(DR2C)
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RAPID5 software
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Given Workstation
Optional DataRecorder Pouch with Shoulder
Strap
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Standard pouch with two plastic side
loops
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Can be used with shoulder strap or
standard DR belt

More convenient carry-on method
Sensor Location Guide for
PillCam® COLON
RAPID® Real-Time
(Real Time Viewer)
The procedure utilizes RAPID Real-Time to confirm Capsule exit from the
stomach prior to 1st administration of laxative post Capsule ingestion
PillCam® COLON
 The colon challenge
 The product
 Prep and procedure
 Potential benefits
 Indications
The Colon Challenge
 Image the entire colon
 Clean the colon
 Propel the Capsule
Colon Cleansing

Colon cleansing level must be maintained throughout the transit of PillCam
COLON up to 8 hours

Colon residue cannot be removed as done during traditional colonoscopy via
rinse and vacuum
Poor-fair cleansing
Good-excellent cleansing
PillCam® COLON Propulsion
 Should be excreted within ~9-10 hours post ingestion
 Colon has only ~6 longitudinal contractions per day
 Motility stimulants (prokinetic tablets) are required to
enhance Capsule
propulsion
Typical PillCam location at 10 hours post ingestions
Standard Colonoscopy prep
PillCam COLON prep
60%
20%
20%
10%
10%
90%
Colon Prep and Procedure
Requirements
• Clean colon duration
• Transparent see through
media in colon
• Motility stimulants
Traditional
Colonoscopy
PillCam
COLON
~ 2 hours
~ 8 hours
Air
(colon inflated)
Fluid
(“natural” colon)
No
Yes
PillCam® COLON Prep and Procedure

Traditional colon prep is used until Capsule ingestion
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During the ingestion day additional laxatives and prokinetic tablets are
provided to the patient
• Maintain a clean colon throughout the transit of
PillCam in the colon
• Enhance Capsule propulsion and excrete it within ~10
hours post ingestion
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The specific laxative and prokinetic tablets
• Dependent on product availability in each country
• Prescribed within their permitted dose
PillCam® COLON Prep and Procedure
•
As with traditional colonoscopy, it is the responsibility of the physician to
prescribe the appropriate PillCam COLON prep and procedure
•
Given Imaging offers specific prep and procedure regimens for clinical
trials only
•
Given imaging provides the following Patient Instructions for commercial
use:
•
Patients Instruction samples, filled in with information provided in
published clinical trials with PillCam COLON
•
Patient Instructions template to be filled in by the physician (should
be based on information provided in published clinical trials with
PillCam COLON)
PillCam® COLON is not cleared for marketing or available for commercial
distribution in the USA [510(k) pending]
Base Line Procedure (Deviere)
Traditional colonoscopy prep:
Day -1
•
•
All day
1800 -2100
600-700
Exam day
•
•
Clear liquid diet (no breakfast)*
3 liter Colopeg
1 liter Colopeg
745
20mg Domperidone
800
Capsule ingestion
1000 (1)
Booster 1 (45 ml NaP)
1400
Booster 2 (30 ml NaP)
1500
Optional light snack
1630
10mg Bisacodyl suppository
Colonoscopy
(1) – Pending capsule exit from stomach (real time viewing)
PillCam® COLON Benefits
 Direct visualization of colon mucosa
 No sedation
 No intubation
 No insufflation
 No radiation
 Potential to improve patient compliance to
colon examination and screening
PillCam® COLON Key Messages
 PillCam COLON provides a patient-
friendly option for visualization of the
colon mucosa.
 PillCam COLON is complementary to
traditional colonoscopy and an
appropriate exam for those patients who
– have received incomplete colonoscopy
– are contraindicated or
– are unwilling to undergo traditional colonoscopy
How to read a PillCam COLON video?
Double Head Viewing
Double Head Viewing
Click to view green
head images only
Green Head Viewing
Green Head Viewing
Click to view yellow
head images only
Yellow Head Viewing
Yellow Head Viewing
Click for double
head viewing
Double Head Viewing
Schematic Colon Track
Tracing tool allowing convenient and quick identification of the colon section which
is currently being viewed
 For localization purposes, the colon is
schematically divided into 3 segments:
a. Right (Cecum to Hepatic flexure)
b. Transverse (Hepatic to Splenic flexures)
c. Left (Splenic flexure to body exit)
 The segment of the colon currently being
viewed turns white
b
a
c
Schematic Colon Track
Tracing tool allowing convenient and quick identification of the colon section which
is currently being viewed
 For localization purposes, the colon is
schematically divided into 3 segments:
a. Right (Cecum to Hepatic flexure)
b. Transverse (Hepatic to Splenic flexures)
c. Left (Splenic flexure to body exit)
 The segment of the colon currently being
viewed turns white
 The Colon Track is activated after the
following anatomical sites are landmarked:
1. Cecum
2. Hepatic flexure
3. Splenic flexure
4. Body exit
Each circle turns
yellow after
landmarked
b
a
c
PillCam® COLON Images:
Spectrum of Colon Disease