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Electrogastrogram Overview
The 3CPM Company, 3CPM
Electrogastrogram (EGG) is the first FDA-cleared, patented,
non-invasive, diagnostic device that records, stores, displays and
prints the myoelectric signals from the stomach as an aid to the
diagnosis of potential and known gastric motility disorders. The
significant advantage is that, it is only via a stimulatory challenge
to the stomach, in this case a water load, that the device is able to
uncover and detect motility abnormalities.
This 3CPM Analyzer is
intended for use as a diagnostic device that receives records and
produces a visual display of the myoelectrical
signal produced by the stomach. It is to be used to record an
Electrogastrogram, as a component of a comprehensive clinical
evaluation in patients with symptoms
consistent with known or suspected gastrointestinal motility
disorders.
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The
Center for Devices and Radiology Health (CDRH) of the Food and Drug
Administration completed its review for the classification of the
(3CPM) EGG Machine designed by 3CPM on August 20, 1999.
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The
3CPM device is classified as a Class II device with clearance to
market as an Electrogastrography (EGG) System under FDA regulations
(21 CFR 807) under 510(k) number K984637.
Example of normal Vs
abnormal gastric activity found in patients with GERD |
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Clinical Data
Patient
Preparation and test protocol ?
If consistent
with patient well being, drugs that stimulate or suppress
myoelectrical or contractile activity should be discontinued 72 hours
before the EGG.
After an
overnight fast, the patient consumes 4 ounces of apple juice and two
pieces of dry toast two hours prior to the start
of the EGG, then fasts for two hours immediately preceding the
procedure.
Conduct the test
in a quiet room with the patient positioned in a comfortable chair or
recliner
15 minute
baseline EGG recording, followed by the Water Load Test and a 30
minute EGG recording
EGG and the Water Load Test(WLT)
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WLT is a
provocative test of gastric distention/capacity
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Water does not
evoke a CCK, insulin, secretin hormonal response like caloric loads
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No effect on
colon
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WLT allows for
a shorter test vs. meal tests
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WLT is
reproducible in healthy control subjects and patients
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Reproducibility of Water Load Test in Controls and Patients with
Functional Dyspepsia
3CPM As a Clinical Tool
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Invented,
developed and validated by a practicing gastroenterologist
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First EGG
cleared by the FDA for clinical use based on over 15 years of
clinical data
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Over 10,000
clinical EGGs recorded
EGG Frequency Ranges
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Normal – 2.5 –
3.75 cpm
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Bradygastria –
1.0 - 2.5 cpm
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Bradygastria (1.0 – 2.5 cpm)
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Abnormal Spectral Analysis
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Bradygastria (1.0 – 2.5 cpm) converted to Normal 3CPM activity
during Cisipride treatment
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Tachygastria –
3.75 – 10.0 cpm
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Pre & Post Tegaserod
3CPM EGG Clinical Settings
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University
Setting - (Harvard, Cornell, Columbia, Cleveland Clinic, Mayo
Clinic, Wake Forest)
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Private
Practice (Group, Multi-specialty, solo physician practice)
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Endoscopy/Surgi-Centers
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Adult and Ped.
GI, Surgeons, Endocrinologist
Pre Stretta & Post Stretta
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Pre & Post Stretta Frequency
Pre Dilation & Post Dilation
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Pre & Post Dilation Frequency
What is
the training process for new customers?
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Extensive onsite and continuing
training with the most experienced staff skilled in performing and
interpreting EGG studies
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