User's Manual

Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—UGI 13
Accuracy of the Device—UGI
The PillCam Capsule Endoscopy System with the PillCam UGI capsule was evaluated in adults with
acute upper gastrointestinal hemorrhage who were hemodynamically stable presenting to the
emergency departments of two academic medical centers
There were 49 patients enrolled in the clinical study of which 46 patients underwent an UGI capsule
endoscopy (CE, PillCam ESO 2), and 47 patients underwent an upper endoscopy examination within 12
to 24 hours. One patient was unable to swallow the CE capsule. The results from the patients with
completed CE examinations demonstrated the presence of blood in the upper gastrointestinal tract in 15
patients. The results of the EGD examination for the 15 patients with blood in the upper gastrointestinal
tract included 8 (53%) patients with normal or non-clinically significant findings which included:
• Normal: n = 2
• Hiatal hernia: n = 1
• Esophagitis: n = 2
• Gastritis/Duodenitis: n = 3
There were 16 (35%) patients that had no evidence of blood in the upper gastrointestinal tract at the time
of the CE examination, but had clinically significant lesions identified at the time of upper endoscopy
examination which included:
• Mallory-Weiss tear: n = 1
• Esophageal varices: n = 1
• Gastric/Duodenal ulcers: n = 11
• Gastric masses: n = 3
The results are summarized in the below table [1]:
Diagnosis and detection of gross blood by capsule endoscopy compared to EGD
No Patient
Detection of
Gross blood
by Capsule
endoscopy
Detection of
Gross blood
by EGD
Diagnosis Based on CE
Findings
Diagnosis
Based on EGD
Findings
1 001SIT No No Gastric Ulcer in antrum Gastric Ulcer,
Gastritis
2 002GBA No No Duodenitis Duodenal
Ulcer, gastritis
3 003VSA Yes No Normal Normal
4 004KAY Yes Yes Esophageal Varices Esophageal
Varices
5 005ZOV No No Gastric Ulcer Normal
6 006ROY Yes No Coffee grounds Gastritis, duo-
denitis