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Surveillance of Bleeding Peptic Ulcer Using Wireless Capsule Endoscopy

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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 Phase
Bleeding Peptic Ulcer Device: Endoscopic placement of Capsule endoscope adjacent to the peptic ulcer Phase 3

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Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

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
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00164827


Contacts
Contact: Enders KW Ng, MD 26322627 endersng@surgery.cuhk.edu.hk
Contact: Philip WY Chiu, MBChB, FRCSEd 26322627 pwychiu@netvigator.com

Locations
China
Endoscopy Center, Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Enders KW Ng, MD    26322627    endersng@surgery.cuhk.edu.hk   
Contact: Philip WY Chiu, MBChB,FRCSEd    26322627    pwychiu@netvigator.com   
Sub-Investigator: Philip WY Chiu, MBChB, FRCSEd         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Enders KW Ng, MD Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
More Information

ClinicalTrials.gov Identifier: NCT00164827     History of Changes
Other Study ID Numbers: CRE-2002-412-T
CUHK4382/03M
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Ulcer
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage