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Evaluation the Performance of Given Diagnostic System in Detection of Bleeding Events in the Small Bowel

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Terminated
CT.gov ID
NCT01441219
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
12
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 oesophagogastroduodenoscopy (OGD) and colonoscopy. Thanks for the latest technological advancement for investigating small intestine, we are now capable of obtaining intraluminal images safely through capsule endoscopy (CE). Its role in obscure gastrointestinal bleeding, Crohn's disease and other small bowel pathologies has already been proven, and nowadays it is suggested by various authorities to be the first-line modality among all small bowel investigations.

The investigators group has showed that CE can alter the clinical management of patients with OGIB - patients with negative CE has lower rebleeding rate, and therefore we may adopt a conservative approach for them. Although supported by some other group as well, conflicting results were still reported in the literature about the out-come of these patients. The main criticisms for these studies are that, CE can only identify 61% of the underlying small bowel bleeding pathology, and one can never ascertain the outcome of patients with negative CE examination. Apparently there is still room for improvement in the current CE technology.

Condition or Disease Intervention/Treatment Phase
  • Device: Colon 2
 Phase 2/Phase 3

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 enhance the coverage of colonic mucosa visualization. An improved generation of this colon capsule, named PillCam Colon 2TM, is also in its developmental phase. With the new "adaptive frame rate" (AFR) technology, the CE optimizes the visual coverage of the bowel by increasing the frame rate up to 35 frames per second when the capsule is moving quickly in certain areas, while decreasing the frame rate down to 4 frames per second when the capsule is moving slowly or remains stationary so as to conserve the battery life. Preliminary data from colorectal cancer screening has shown that it could improve the diagnostic yield of colonic polyps.

The investigators hypothesize that, by re-programming the PillCam Colon 2TM so as to initiate AFR since ingestion, it could improve the visualization of small intestinal lumen and hence improves the sensitivity of small bowel CE examination.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation the Performance of Given Diagnostic System in Detection of Bleeding Events in the Small Bowel: a Single-arm Prospective Cohort Study.
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Colon 2

using Colon 2 capsule in detecting bleeding events in small bowel

Device: Colon 2
Ingest one colon 2 capsule
Other Names:
  • C2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic yield for bleeding events in the small bowel [1 year]

      Review the capsule video to detect the bleeding events.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 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)

    2. Patients with occult GI bleeding (Faecal occult blood test,FOBT +)

    3. Patients with suspected arteriovenous(AV) malformations.

    4. Patients treated with nonsteroidal antiinflammatory drugs (NSAIDs)

    5. Patients with active Crohn's disease(CD), with no evidence of obstruction

    Exclusion Criteria:

    1. In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-ingestion testing and profile.

    2. In patients with cardiac pacemakers or other implanted electromedical devices.

    3. In patients with dysphagia or other swallowing disorders.

    4. Unable to obtain informed written consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Hong Kong China

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Joseph JY Sung, MD, CUHK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Francis KL Chan, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT01441219
    Other Study ID Numbers:
    • C2 in SB
    First Posted:
    Sep 27, 2011
    Last Update Posted:
    Mar 5, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Gastrointestinal Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Mar 5, 2013