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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01441219
Recruitment Status : Terminated (Results were obtained in another project.)
First Posted : September 27, 2011
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong

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
Gastrointestinal Hemorrhage 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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 : January 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: C2

Primary Outcome Measures :
  1. Diagnostic yield for bleeding events in the small bowel [ Time Frame: 1 year ]
    Review the capsule video to detect the bleeding events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01441219

Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Joseph JY Sung, MD CUHK

Responsible Party: Francis KL Chan, Professor, Chinese University of Hong Kong Identifier: NCT01441219     History of Changes
Other Study ID Numbers: C2 in SB
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases