Status:
TERMINATED
Evaluation the Performance of Given Diagnostic System in Detection of Bleeding Events in the Small Bowel
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Gastrointestinal Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Obscure gastrointestinal bleeding (OGIB) has been one of the most challenging area in the field of gastroenterology, as small bowel is beyond the reach of ordinary endoscopes like oesophagogastroduode...
Detailed Description
Newer generation of CE (PillCam ColonTM) has been developed to investigate the large bowel. It is different from small bowel CE that it consists of two cameras at both ends of the capsule, so as to en...
Eligibility Criteria
Inclusion
- Patients with overt GI bleeding (hematemesis, coffee-grounds, rectal bleeding and/or melena) with negative OGD but not critically ill, who should read positive on small bowel investigation (SBI)
- Patients with occult GI bleeding (Faecal occult blood test,FOBT +)
- Patients with suspected arteriovenous(AV) malformations.
- Patients treated with nonsteroidal antiinflammatory drugs (NSAIDs)
- Patients with active Crohn's disease(CD), with no evidence of obstruction
Exclusion
- In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-ingestion testing and profile.
- In patients with cardiac pacemakers or other implanted electromedical devices.
- In patients with dysphagia or other swallowing disorders.
- Unable to obtain informed written consent
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01441219
Start Date
January 1 2011
End Date
January 1 2012
Last Update
March 5 2013
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, China