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Surveillance of Bleeding Peptic Ulcer Using Wireless Capsule Endoscopy

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: NCT00164827
Recruitment Status : Unknown
Verified September 2005 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
Information provided by:
Chinese University of Hong Kong

Brief Summary:
To investigate the adjunctive role of "Capsule Endoscope" in continuous endoscopic monitoring and early detection of recurrent ulcer bleeding after endoscopic therapy in patients presenting with bleeding peptic ulcers

Condition or disease Intervention/treatment
Bleeding Peptic Ulcer Device: Endoscopic placement of Capsule endoscope adjacent to the peptic ulcer

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Study Type : Observational
Enrollment : 50 participants
Observational Model: Defined Population
Time Perspective: Prospective
Official Title: Phase 3 Study on the Use of Capsule Endoscope for Surveillance and Detection of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
Study Start Date : January 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with bleeding peptic ulcers; ulcer actively bleeding or with major stigmata of visible vessels ( protuberant discolorations in ulcer bases) and clots (Forrest I, IIa and IIb ulcers) seen at endoscopy performed within 24 hours of their admissions.
  • Endoscopic hemostasis achieved (with defined endpoints).
  • Age > 18
  • Provision of an informed written consent signed by the patient.

Exclusion Criteria:

  • The present of an intercurrent ulcer complication precluding endoscopic treatment such as gastric outlet obstruction or ulcer perforation mandating surgical intervention.
  • Patients with clinical suspicion of intestinal obstruction, stricture and fistula.
  • Patient with cardiac pacemaker, or any implanted electromedical device.
  • Age <18
  • Pregnancy
  • moribund patients e.g. patients with terminal malignancy
  • Patient unable to give 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): NCT00164827

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Contact: Enders KW Ng, MD 26322627
Contact: Philip WY Chiu, MBChB, FRCSEd 26322627

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Endoscopy Center, Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Enders KW Ng, MD    26322627   
Contact: Philip WY Chiu, MBChB,FRCSEd    26322627   
Sub-Investigator: Philip WY Chiu, MBChB, FRCSEd         
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Enders KW Ng, MD Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Layout table for additonal information Identifier: NCT00164827    
Other Study ID Numbers: CRE-2002-412-T
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage