Iron Deficiency AnemiaNCT00694954
Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding
A study testing Diagnostic Test - Given Imaging Pillcam and Diagnostics in people with Iron Deficiency Anemia, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Diagnostic Test - Given Imaging Pillcam and Diagnostics
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding
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.
Read the detailed description
Patients with iron deficiency anemia from suspected occult GI bleeding will be randomized to receive CE or usual standard care following a negative gastroscopy and colonoscopy. Our primary outcome measure (diagnostic yield) and secondary outcome measures (noted below) will be determined after one year of followup. Patients with have a minimum of one year of clinical followup. Direct health care costs in each arm of the study will be determined after a minimum of two years of followup.
An economic evaluation based on the results of the clinical trial is also planned.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Diagnostic Test - Given Imaging Pillcam, Diagnostics
- Keywords
- Iron deficiency anemia, Wireless capsule endoscopy, Obscure-occult gastrointestinal bleeding
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test - Given Imaging PillcamDevice
Also called Capsule endoscopy, Given Imaging Pillcam, Pill camera
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)
DiagnosticsOther
Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Wireless capsule endoscopy Receives: Device: Diagnostic Test - Given Imaging Pillcam |
| 2 | Active comparator | Standard Care Receives: Other: Diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic yield
Measured: 48 weeks
Secondary outcomes (6)
number of blood transfusions
Measured: 48 weeks
number of hospitalizations for GI bleeding/anemia
Measured: 48 weeks
number of GI-related procedures and investigations
Measured: 48
procedure-related complications
Measured: 48
quality of life
measured by 1) SF36 - 8 domains + PCS/MCS, 2) GI Quality of Life Index (GIQLI), 3) EQ-5D - index + visual analogue scale
Measured: 48
health care costs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startFeb 2007
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Calgary Health Region
- Responsible party
- Principal investigator, Dr. Robert Hilsden, University of Calgary
- Investigators
- Catherine J. Dube, MD PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694954
- Sponsor's protocol ID
- E20270
- Other IDs
- Internal tracking #1763
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2007
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT00694954
- Acronym / sponsor ID
- E20270
- Conditions
- Iron Deficiency Anemia
- Keywords
- Iron deficiency anemia, Wireless capsule endoscopy, Obscure-occult gastrointestinal bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Calgary Health Region
- Study start
- Feb 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with iron deficiency anemia from suspected occult GI bleeding will be randomized to receive CE or usual standard care following a negative gastroscopy and colonoscopy. Our primary outcome measure (diagnostic yield) and secondary outcome measures (noted below) will be determined after one year of followup. Patients with have a minimum of one year of clinical followup. Direct health care costs in each arm of the study will be determined after a minimum of two years of followup.
An economic evaluation based on the results of the clinical trial is also planned.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Diagnostic Test - Given Imaging PillcamWireless capsule endoscopy |
| 2 | Active comparator | Other: DiagnosticsStandard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test - Given Imaging PillcamAlso: Capsule endoscopy, Given Imaging Pillcam, Pill cameraProcedure 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) | Device | 1 |
| DiagnosticsAny other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy. | Other | 2 |
Primary outcome
diagnostic yield
Time frame: 48 weeks
6 secondary outcomes
number of blood transfusions
Time frame: 48 weeks
number of hospitalizations for GI bleeding/anemia
Time frame: 48 weeks
number of GI-related procedures and investigations
Time frame: 48
procedure-related complications
Time frame: 48
quality of life
Time frame: 48
health care costs
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine J. Dube, MD PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test - Given Imaging Pillcam and Diagnostics in people with Iron Deficiency Anemia, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic yield (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.