Status:
COMPLETED
A Pilot and Feasibility Study to Evaluate Capsule Endoscopy
Lead Sponsor:
Medtronic - MITG
Conditions:
Upper Gastrointestinal Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 pe...
Eligibility Criteria
Inclusion
- age ≥ 18 years
- history of acute, overt UGI hemorrhage, defined as hematemesis (fresh blood or coffee grounds) and/or melena within the 48 hours prior to patient presentation
Exclusion
- dysphagia
- odynophagia
- known swallowing disorder
- history of Zencker's diverticulum
- suspected bowel obstruction or bowel perforation at the time of presentation
- UGI hemorrhage with hemodynamic shock requiring urgent endoscopy
- history of prior bowel obstruction
- history of Crohn's disease
- history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
- presence of an electromedical device (pacemaker or internal cardiac defibrillator)
- altered mental status (e.g., hepatic encephalopathy) at the time of presentation that would limit patient ability in swallowing the capsule
- pregnancy
- known allergy to conscious sedation medications
- known allergy to erythromycin
- inability to provide written informed consent
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00974701
Start Date
August 1 2009
End Date
November 1 2010
Last Update
July 31 2019
Active Locations (2)
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1
Prince of Wales Hospital, Hong Kong, China
Shating, N.T., Hong Kong
2
Rambma Medical Center
Haifa, Israel, 31096