NCT00164827

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 14, 2005

Status Verified

September 1, 2005

First QC Date

September 11, 2005

Last Update Submit

September 11, 2005

Conditions

Bleeding Peptic Ulcer

Interventions

Endoscopic placement of Capsule endoscope adjacent to the peptic ulcerDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Enders KW Ng, MD

    Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enders KW Ng, MD

CONTACT

26322627endersng@surgery.cuhk.edu.hk

Philip WY Chiu, MBChB, FRCSEd

CONTACT

26322627pwychiu@netvigator.com

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

January 1, 2003

Last Updated

September 14, 2005

Record last verified: 2005-09

Locations

CN(1)