User's Manual

PillCam Capsule Endoscopy
12 Accuracy of the Device—ESO
Accuracy of the Device—ESO
The PillCam Capsule Endoscopy System with the PillCam ESO 1 capsule was studied in a series of 107
subjects included in the study. Among patients included in this clinical study, 94 subjects had suspected
GERD at the time of the study, and a small group (13 subjects) were diagnosed with Barrett’s prior to the
study.
All patients underwent esophageal capsule endoscopy as well as esophagoscopy, to compare the results of
the esophageal capsule endoscopy with conventional video EGD (imperfect standard) in assessing
endoscopic findings of the esophagus.
1
The study was too small to accurately assess the agreement with lesions other than the most common
findings—esophagitis and suspected Barrett’s esophagus. There were several other lesions which were
noted as depicted in the table below.
Rate of
Agreement
(95% CI)
Rate of False
Pos (95% CI)
Rate of False
Neg (95% CI)
Overall
Agreement
(95% CI)
Esophagitis
85%
(69%; 95%)
13%
(4%; 27%)
12%
(3%; 27%)
Suspected BE
81%
(62%; 94%)
15%
(6%; 30%)
15%
(4%; 34%)
Normal
70%
(53%; 83%)
OVERALL
78.3%
(69%; 86%)
1.Clinical report presented in K041149
# Cases Diagnosed
by EGD
# Cases correctly
Diagnosed by CE
Agreement
Hiatal Hernia
37 6 16%
Stricture
5 1 20%
Polyps/Nodules
3 0 0%
Varices
1 1 100%
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Note
The PillCam ESO 1 capsule was not able to reliably identify:
• Precise location of lesion(s)
• Length or extent of lesion(s)
• Severity or grade of lesion(s)