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Surveillance of Bleeding Peptic Ulcer Using Wireless Capsule Endoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00164827
First received: September 11, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Estimated Enrollment: 50
Study Start Date: January 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00164827     History of Changes
Other Study ID Numbers: CRE-2002-412-T, CUHK4382/03M
Study First Received: September 11, 2005
Last Updated: September 11, 2005
Health Authority: Hong Kong: Department of Health

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

ClinicalTrials.gov processed this record on May 16, 2013