Capsule Endoscopy in Obscure GI Bleeding | NCT00203619

Studies
Capsule Endoscopy in Obscure GI Bleeding

NCT00203619

Sponsor

University of Calgary

Status

Completed

Last Update Posted

Dec 5, 2017Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Obscure Gastrointestinal Bleeding

Interventions

Wireless capsule endoscopy
standard care

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2016Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2017

Last Update Posted Date

Dec 5, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Robert Hilsden, Associate Professor, Department of Medicine & Research Director, Colon Cancer Screening Centre, University of CalgaryPrincipal Investigator

Lead Sponsor

University of CalgaryOTHER

Collaborators

Name	Class
Alberta Heritage Foundation for Medical Research	OTHER
Calgary Health Region	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Wireless capsule endoscopy	Device: Wireless capsule endoscopy
2	Active Comparator	Standard care	Other: standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wireless capsule endoscopy	Device	wire less capsule endoscopy	1
standard care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sf36		48 weeks
giqli		48 weeks
eq50		48 weeks
diagnostic yield		48 weeks

Secondary Outcomes

Measure	Description	Time Frame
transfusions		48 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert J Hilsden, MD PhD	University of Calgary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary		Calgary	Alberta	T2N4N1	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D053704	Capsule Endoscopy
D059039	Standard of Care

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical

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Browse Branches

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