NCT00203619

Brief Summary

The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

10.3 years

First QC Date

September 13, 2005

Last Update Submit

December 1, 2017

Conditions

Obscure Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (4)

  • sf36

    48 weeks

  • giqli

    48 weeks

  • eq50

    48 weeks

  • diagnostic yield

    48 weeks

Secondary Outcomes (1)

  • transfusions

    48 weeks

Study Arms (2)

1

EXPERIMENTAL

Wireless capsule endoscopy

Device: Wireless capsule endoscopy

2

ACTIVE COMPARATOR

Standard care

Other: standard care

Interventions

Wireless capsule endoscopyDEVICE

wire less capsule endoscopy

1
standard careOTHER

standard diagnostic evaluation as decided by treating physician

2

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older
  • Obscure overt GI bleeding
  • No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding

You may not qualify if:

  • Known or suspected swallowing disorders
  • Known or suspected small bowel obstruction
  • Multiple comorbidities precluding surgery
  • Patients with implantable electromagnetic devices
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N4N1, Canada

Location

MeSH Terms

Interventions

Capsule EndoscopyStandard of Care

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Robert J Hilsden, MD PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Medicine & Research Director, Colon Cancer Screening Centre

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

May 1, 2005

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations

CA(1)