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

NCT01441219 | Terminated Phase 2

• 1 other identifier: C2 in SB
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield for bleeding events in the small bowel

  Review the capsule video to detect the bleeding events.

  1 year

Study Arms (1)

Colon 2

EXPERIMENTAL

using Colon 2 capsule in detecting bleeding events in small bowel

Device: Colon 2

Interventions

Colon 2 DEVICE

Ingest one colon 2 capsule

Also known as: C2

Colon 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph JY Sung, MD

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: September 27, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

CN (1)