Transcript SmartPill® System and Procedure Overview

SmartPill® System and Procedure
Overview
5-001-802
SmartPill® Topics
■ Indications & Contraindications
■ System Overview
■ Equipment and MotiliGI® software
■ Procedure Overview
■ How does it work?
■ Patient preparation
■ Activating the capsule
■ Capsule ingestion
■ Post-ingestion
■ Procedure Data
■ Hints & Tips
■ Resources
■Q & A
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SmartPill®: Indications for Use
■ The SmartPill motility monitoring system measures whole gut and regional
gut (stomach, small bowel and colon) transit times. Measurements of
gastrointestinal tract transit times are used for evaluating motility
disorders
■ Gastric transit time (or gastric emptying time, GET) is indicated for the
evaluation of patients with suspected gastroparesis. Delayed gastric
emptying is suggested in such disorders as idiopathic and diabetic
gastroparesis and functional non-ulcer dyspepsia
■ Colonic transit time (CTT) is indicated for the evaluation of colonic transit
in patients with chronic constipation and used to aid in differentiating slow
and normal transit constipation. Combined small and large bowel transit
time (SLBTT) is used as a surrogate measure of colonic transit in patients
with chronic constipation when colonic transit time alone cannot be
determined
■ The system measures pH, pressure and temperature throughout the entire
GI tract. Pressure contraction data from the antrum and duodenum can be
used to calculate motility indices
■ Not for use in pediatric patients (children under the age of 18 years)
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SmartPill®: Contraindications
Contraindications for the SmartPill motility monitoring system
include patients with:
■ A history of gastric bezoars
■ Swallowing disorders
■ Suspected or known strictures, fistulas, or physiological/mechanical GI
obstruction
■ History of gastrointestinal surgery within the past 3 months
■ Severe dysphagia to food or pills
■ Crohn’s disease or diverticulitis
■ Cardiac pacemakers or other implanted electromedical devices
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SmartPill®: Procedure Risk Information
■ Before administering SmartPill, rule out physiological/mechanical
GI obstruction as a cause of patient symptoms
■ Do not perform a Magnetic Resonance Imaging (MRI) until capsule
passage is confirmed by physician review of the MotiliGI® graph or
x-ray of kidneys, ureter and bladder (KUB). If a SmartPill capsule is
in the body during an MRI test, there is a risk of damage to the GI
tract
■ Significant data dropout can occur in severely obese patients
(>40 BMI)
■ The risks of SmartPill motility monitoring include capsule retention
and aspiration
■ Please refer to the product user manual or www.givenimaging.com
for detailed information
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SmartPill® Motility Monitoring System
System consists of:
■ SmartPill capsule
■ SmartBar®
■ SmartPill recorder
■ Docking station
■ Activation fixture
■ MotiliGI® software
■ Computer workstation
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SmartPill® Capsule
■ Capsule pack contains:
■ 1 capsule
■ 1 bottle of calibration fluid
■ 1 instructions for use (IFU) manual
■ 1 patient diary
■ Capsule is latex-free
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SmartPill® Recorder
Functions and Features
■ Records the data transmitted by the SmartPill capsule
■ 5+ days of recording on a fully charged battery
■ Holds the patient diary
■ Event button turns the recorder on and marks events
■ Backlight control button – lights data display
■ LCD displays real-time pH, pressure, capsule function
and signal strength
■ Attaches by belt clip or lanyard
■ Caution: Recorder must be fully charged in the OFF
position before starting a test. Failure to charge in
the OFF position can result in test data loss.
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Turning Off the Recorder
■ If the data display is blank, the recorder is OFF. If the data display
shows any characters, the recorder is ON.
■ Turn the recorder OFF by simultaneously depressing the backlight
control button and the event button on the front of the recorder for
approximately five seconds or until the backlight goes out. If the
recorder display is still showing text or data, repeat this step.
Data display
is blank
Recorder in ON position
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Recorder in OFF position
SmartPill® Docking Station
Functions and Features
■ Cradles recorder and transfers data to the system
computer
■ Charges the recorder
■ LED glows red while charging
■ LED glows green when fully charged
■ LED glows yellow if there is a problem with the
docking station
■ Always charge recorder in the “OFF” position
■ May take up to 5 hours to fully charge
■ Well holds the SmartPill capsule container
Activation Fixture
■ Turns the SmartPill capsule ON and OFF
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SmartPill® MotiliGI Software
■ Automatically processes data and displays test results:
■ Gastric emptying time
■ Antral duodenal pressure
■ Small bowel transit time
■ Colonic transit time
■ Combined small/large bowel transit time
■ Whole gut transit time
■ Complete test results are available for review and analysis in
minutes
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Patient Indications / Selection
■ Patients present with:
■
■
■
■
■
Nausea
Bloating
Constipation
Pain
Vomiting
Upper and lower gut symptoms often overlap; therefore,
localizing transit abnormalities to a specific GI region is
important in diagnostic evaluation and should be done early in
the process to guide appropriate therapy.1
1Lin
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et al. Measurement of Gastrointestinal Transit. Digestive Diseases and Sciences 2005; 50:989.
How Does It Work?
■ Patient fasts overnight
■ Patient ingests a SmartBar®, swallows the
SmartPill® capsule and wears the SmartPill
recorder
■ Patient goes about normal daily activities
throughout the test. The data transmits
to the recorder for up to 5 days
■ Patient returns the recorder to the
physician’s office where the data is
downloaded to the computer
■ Physician utilizes MotiliGI® software to
graphically display test data and clinical
end points
■ Physician reviews collected data to
generate interpretation and report
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SmartPill® Patient Preparation
Food and Drink
■ Fast 8 hours before the test
■ Water is okay
■ After ingestion of the standardized meal and the SmartPill,
the patient will fast again for 6 hours
Refer to the patient instruction sheet and provide to patients
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SmartPill® Patient Preparation
Medications
■ Discontinue gastric pH altering medications such as proton pump
inhibitors 7 days before the test
■ Discontinue histamine blockers 2 days before the test
■ Discontinue antacids one day before the test
■ Insulin-dependent patients: Instruct them to take ½ of their normal
morning dose and monitor glucose levels according to normal routines
These medication restrictions were used during SmartPill clinical
studies and provide an environment for optimal test results.
Medication restrictions are ultimately at the doctor’s discretion.
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Pre-test Practitioner Preparation
Before opening the capsule pack, verify:
■ The patient has arrived
■ The patient has followed the pre-test instructions
■ The recorder is fully charged
■ The capsule packaging is intact and expiration date has
not been exceeded
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Activating the SmartPill Capsule
Capsules are very sensitive to the activation fixture and proper
technique is important when activating. If you are unable to activate
a capsule after three attempts, please call SmartPill Technical
Support.
Fig. 1
1. Orient the activation fixture so
“ON” is at 9 o’clock (Figure 1).
2. Align the capsule container
diamond with the activation
fixture “ON” and place the
capsule container on top of the
activation fixture (Figure 2).
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Fig. 2
“ON” and
diamond at
9 o’clock
12 o’clock
Activating the SmartPill Capsule
3. While keeping the capsule container
level, quickly lift the container 6
inches directly above the activation
fixture; do not rotate, tilt or shake.*
Fig. 3
The capsule is now activated and
must be kept at least 6 inches from
the activation fixture at all times
(Figure 3).
6”
Fig. 4
4. Set the capsule container into the docking station
well.
Complete Step 6 in MotiliGI’s wizard: Select
capsule to ensure the capsule is activated.
*We recommend holding the base of the
activation fixture and using the opposite hand to
grip and lift the container (Figure 4).
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SmartBar® – Standardized Meal
To accurately measure gastric emptying time, patients must consume a
standardized meal immediately before ingesting the SmartPill Capsule. SmartBar is
an FDA cleared replacement for the standard egg beater meal (Tougas)1:
■ Included with every capsule purchase
■ Standardizes procedure
■ No preparation required
Ingredients: Whey crisp, rolled oats, rice syrup, corn syrup, invert sugar, concentrated whey protein, puffed
wheat, apple juice concentrate, glycerine, molasses, contains 2% or less of: honey, defatted wheat germ,
dried apples, dried cranberries, partially hydrogenated vegetable shortening (soy and/or cottonseed oils),
natural and artificial flavors, potassium sorbate (as preservative), salt, vanilla.
Nutritional
Composition
(in % of weight)



75% carbohydrate
21% protein
3% fat


3% fiber
255 kcal
Note: The standard egg beater meal (Tougas)1 may be used as a substitute for those patients with dietary restrictions.
Performance characteristics of the SmartPill capsule were determined through use of the SmartBar and the standard egg
meal. The effect on test results using an alternative substitute meal (e.g., to address a known food allergy) is not
known.
[1] Tougas G., McCallum R.W. Assessment of gastric emptying using a low fat meal: establishment of international control values.
Am J Gastroenterol 2000;95(6):1456-62.
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Patient Instructions – Post-ingestion
■ Event button and patient diary
■ Record bowel movements, meals and other information
of interest
■ Keep recorder on body at all times
■ Recorder can be removed for bathing and sleeping, but must be
kept as close as possible to minimize data loss
■ Instruct the patient to wait 3 minutes in the lavatory before
flushing the toilet after each bowel movement
■ Refrain from using laxatives, anti-diarrhea and other
motility affecting medications until the capsule has passed
■ Avoid vigorous exercise such as abdominal crunches and
prolonged aerobic activity (greater than 15 minutes) during
the monitoring period
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Patient Instructions – Post-ingestion
■ No food for 6 hours after ingesting the capsule; A normal
diet can be resumed at 6 hours
■ Diabetic patients should monitor glucose levels and
follow their personal treatment plan
■ Schedule return of recorder
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Capsule/Recorder Communication
Time of Day
(hours:min)
Recorder Signal
Strength
Capsule Status
Solid, as shown, means Ok
“X”: means capsule failure
Recorder Status
Solid, as shown, means Ok
“X”: means capsule failure
Flashing Indicates Recorder is
Writing Data from the Capsule
Pressure Value
pH Value
Flashes when Event
Button is pressed
Capsule Packet Received
(“Radar Symbol” – an “X” means packet missed)
Recorder Battery Life
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Whole Gut Transit and Motility
SmartPill® Tracing
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MotiliGI® Landmarks
Gastric
Transit
Small Bowel
Transit
Colonic Transit
ICJ
Gastric Emptying
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Confirming Body Exit
Bowel Movement Event
Marker
Temperature Drop
Abrupt Loss of Data
Confirm by one of the following methods:
■ Patient observation of the capsule in their stool
■ An abrupt drop in temperature on the MotiliGI graph and/or loss of signal which coincides
with a bowel movement recorded in the patient diary
■ A KUB exam (Note: If the capsule is present in the colon, a KUB exam is not necessary )
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Capsule Low Voltage Indication
Data collected during and after a low voltage state may not be valid.
■ A temperature drop under low voltage cannot be used as confirmation of
capsule exit. Monitor the patient for symptoms of capsule retention OR
confirm capsule exit by KUB
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SmartPill® Report
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Care & Maintenance: Recorder/Docking Station
■ Clean and disinfect the recorder after each use by wiping
the outside surfaces using a damp cloth with a mild
detergent and water or disinfectant
■ Do not use water or liquids to clean the docking station.
■ The recorder, docking station, power supply and capsule
are NOT user serviceable. Do not attempt to replace
batteries
■ Do not immerse any of the SmartPill components in water
or other solutions
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SmartPill®: Hints & Tips
Patient Selection
■ Significant data dropout can occur in severely obese patients
(>40 BMI)
SmartPill Storage & Handling
■ The SmartPill capsule is single use only. Do not reuse.
■ Do not use SmartPill capsules after the labeled expiration
date found on the individual capsule package
■ Do not expose the SmartPill capsule to UV light. UV light can
permanently damage the pH sensor
■ Keep the capsule at least six (6) inches away from the
activation fixture. Stray magnetic fields from the activation
fixture may activate or deactivate the capsule
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SmartPill®: Hints & Tips
SmartPill activation and calibration
■ If capsule fails to activate:
■ Ensure the recorder is properly connected to the docking station
■ Back-up MotiliGI® and attempt capsule reactivation
■ Assure proper capsule placement in capsule tray
■ Keep the capsule in the buffer solution until the patient is
ready to ingest the capsule. Removing the capsule from the
buffer solution may degrade pH accuracy
■ If a test is aborted before capsule ingestion and the capsule
has been exposed to buffer solution, deactivate the capsule
and use within two (2) hours
■ If a test is aborted before capsule ingestion and the capsule
has not been exposed to buffer solution, deactivate the
capsule and use within one month
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SmartPill®: Hints & Tips
Docking station/recorder connectivity
■ To ensure proper charging of the recorder and to prevent
damage to the recorder, mate the recorder firmly along the
same angle with the back of the docking station
■ Foreign material on the contact pins can be removed with IPA
or compressed air
Test meal
■ The test meal must be consumed immediately before capsule
ingestion. Do not have the patient consume the meal before
capsule calibration is complete
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Patient Resource:
SmartPill® Patient Brochure
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Clinician Resources
■ A user manual is available in
electronic format
■ The pdf is accessed from the
MotiliGI® Help tab
■ This training is not intended to
substitute for reading and
understanding the instructions
provided in the user manual
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Clinician Resources
■ Given Imaging Technical Support 800-448-3644 option 3
■ 7 am – 8 pm Eastern Time Monday – Friday
■ 8 am – 5 pm Eastern Time weekends and holidays
■ Reimbursement Helpline: 888-389-5200
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Questions?
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