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Ø11 mm. 31 mm. PillCam ® COLON Capsule. 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.

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Pillcam colon capsule

Ø11 mm

31 mm

PillCam® COLON Capsule

  • 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


Pillcam colon capsule sleep mode
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
DataRecorder and RAPID®

  • SensorArray 8

  • 10GB DataRecorder (DR2C)

  • RAPID5software

  • Given Workstation


Optional DataRecorder Pouch with Shoulder Strap

  • Standard pouch with two plastic side loops

  • Can be used with shoulder strap or standard DR belt

  • More convenient carry-on method



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


Poor-fair cleansing

Good-excellent cleansing

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


Standard Colonoscopy prep

60%

20%

10%

10%

20%

90%

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

PillCam COLON prep



PillCam® COLON Prep and Procedure

  • Traditional colon prepis used until Capsule ingestion

  • 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

  • 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
Base Line Procedure (Deviere)

(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



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:

    • Right (Cecum to Hepatic flexure)

    • Transverse (Hepatic to Splenic flexures)

    • 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:

    • Right (Cecum to Hepatic flexure)

    • Transverse (Hepatic to Splenic flexures)

    • 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:

    • Cecum

    • Hepatic flexure

    • Splenic flexure

    • Body exit

b

a

c

Each circle turns yellow after landmarked


PillCam® COLON Images:Spectrum of Colon Disease


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