NCT00694954

Brief Summary

The role of capsule endoscopy (CE) in patients with obscure / occult gastrointestinal (GI) bleeding remains unclear. This pragmatic randomized controlled trial is designed to determine the diagnostic yield and clinical outcomes of patients with obscure GI bleeding who receive CE compared to those who receive usual standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

8.8 years

First QC Date

December 14, 2007

Last Update Submit

December 1, 2017

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemiaWireless capsule endoscopyObscure-occult gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

  • diagnostic yield

    48 weeks

Secondary Outcomes (6)

  • number of blood transfusions

    48 weeks

  • number of hospitalizations for GI bleeding/anemia

    48 weeks

  • number of GI-related procedures and investigations

    48

  • procedure-related complications

    48

  • quality of life

    48

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Wireless capsule endoscopy

Device: Diagnostic Test - Given Imaging Pillcam

2

ACTIVE COMPARATOR

Standard Care

Other: Diagnostics

Interventions

Diagnostic Test - Given Imaging PillcamDEVICE

Procedure performed once only after randomization. If procedure is incomplete due to a number of variables, procedure may possibly need to be repeated. Diagnostic possibilities: normal exam, active bleeding, potential source of bleeding (angiodysplasia, ulcer, tumor)

Also known as: Capsule endoscopy, Given Imaging Pillcam, Pill camera
1
DiagnosticsOTHER

Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.

2

Eligibility Criteria

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

You may qualify if:

  • Adult patients age over 18years with iron deficiency anemia (IDA). IDA is defined as hemoglobin \<137g/L in men or \<120g/L in women with serum ferritin level \<22ug/L in men and \<10ug/L in women.
  • Eligible patients should have a negative gastroscopy and negative colonoscopy within 1 year prior to entry into study.
  • Negative celiac screen and /or negative small bowel biopsies

You may not qualify if:

  • Overt gastrointestinal bleeding
  • Premenopausal women with menorrhagia
  • Known or suspected small bowel obstruction
  • Serious medical co-morbidities precluding surgery given the risk of capsule impaction
  • Pregnancy
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Catherine J. Dube, 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

Study Record Dates

First Submitted

December 14, 2007

First Posted

June 11, 2008

Study Start

February 1, 2007

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations

CA(1)