Upper Gastrointestinal Hemorrhage Clinical Trial
Official title:
A Pilot and Feasibility Study to Evaluate Capsule Endoscopy in Subjects Presenting With Acute, Overt Upper Gastrointestinal Hemorrhage
This study is aimed at assessing the capability of the PillCam Platform using the PillCam ESO
2 Capsule in:
- Determining whether there is 1) active bleeding in the Upper gastrointestinal (UGI)
tract, 2) identifying the anatomic location of acute overt UGI bleeding, and 3)
discriminating a variceal versus non-variceal source of UGI bleeding.
Upper gastrointestinal hemorrhage (UGIH) is a prevalent, clinically significant, and
expensive healthcare problem worldwide. The incidence of acute, overt UGIH has been estimated
to be 50-150 cases per 100,000 adults in the United States population each year.
Clinical Significance / Rationale EGD is the currently accepted community standard for the
diagnosis and management of UGIH. Diagnostic EGD in persons presenting with acute UGIH allows
for (1) differentiating the source of bleeding (variceal vs. non-variceal), (2) defining the
anatomic location of the bleeding site (e.g., esophagus, stomach, duodenum), (3) providing an
endoscopic diagnosis, and (4) facilitating patient triage for subsequent level of care (ICU,
monitored bed, non-monitored bed, early / expedited hospital discharge).
Capsule endoscopy for the small bowel was cleared by the FDA in 2001, and within a short
time, has gained acceptance as providing state-of-the-art endoscopic imaging. Capsule
endoscopy is now commonly used in the evaluation of patients with obscure gastrointestinal
bleeding, including iron deficiency anemia, suspected and known Crohn's disease,
malabsorption syndromes (e.g., Celiac disease), and chronic abdominal pain. Capsule endoscopy
technology is now also being applied to evaluation of the esophagus (PillCam® ESO, Given
Imaging, Ltd, Yoqneam, Israel) and the colon (PillCam® COLON). Recently, a second generation
esophageal capsule endoscope (PillCam® ESO 2, Given Imaging Ltd, Yoqneam, Israel) was cleared
by the United States Food and Drug Administration in June 2007. While having the same outer
dimensions (length and diameter) as the original PillCam ESO capsule, several significant
improvements have been made to the internal components of the PillCam ESO 2. Similar to the
original PillCam ESO, the system includes a sensor array and data recording device which are
connected to the patient during the procedure. The recorded data is downloaded into the Given
Imaging RAPID® workstation for review of the capsule endoscopy video.
However, there are no published detailed data evaluating the feasibility of utilizing PillCam
ESO 2 in individuals presenting with acute, overt UGI bleeding. Moreover, there are no data
comparing PillCam ESO 2 and EGD in the evaluation of this patient population. Therefore, in
this proof-of-concept pilot study, we will evaluate the feasibility and safety of using
PillCam ESO 2 in individuals presenting with acute, overt UGI bleeding.
;
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