Obscure Gastrointestinal BleedingNCT00203619
Capsule Endoscopy in Obscure GI Bleeding
A study testing Wireless capsule endoscopy in people with Obscure Gastrointestinal Bleeding, run by University of Calgary at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obscure Gastrointestinal Bleeding
- What is being tested?
- Wireless capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Sep 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
- Age 18 or older
- Obscure overt GI bleeding
- No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding
Who cannot join
- Known or suspected swallowing disorders
- Known or suspected small bowel obstruction
- Multiple comorbidities precluding surgery
- Patients with implantable electromagnetic devices
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding
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
Read the detailed description
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. Patients randomized 1:1.
- Conditions
- Obscure Gastrointestinal Bleeding
- Being tested
- Wireless capsule endoscopy, standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless capsule endoscopyDevice
wire less capsule endoscopy
standard careOther
standard diagnostic evaluation as decided by treating physician
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Wireless capsule endoscopy Receives: Device: Wireless capsule endoscopy |
| 2 | Active comparator | Standard care Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
sf36
Measured: 48 weeks
giqli
Measured: 48 weeks
eq50
Measured: 48 weeks
diagnostic yield
Measured: 48 weeks
Secondary outcomes (1)
transfusions
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obscure Gastrointestinal BleedingStudies of the same condition, open and under way.
- 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
- 40 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
- Robert J Hilsden, MD PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203619
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2017
- First submitted
- 13 Sep 2005
- 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
- An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT00203619
- Acronym / sponsor ID
- 1
- Conditions
- Obscure Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Calgary Health Region
- Study start
- May 2005
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Sep 2005 (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 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
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. Patients randomized 1:1.
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: Wireless capsule endoscopyWireless capsule endoscopy |
| 2 | Active comparator | Other: standard careStandard 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)
- Age 18 or older
- Obscure overt GI bleeding
- No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding
Key exclusion criteria (5 listed)
- Known or suspected swallowing disorders
- Known or suspected small bowel obstruction
- Multiple comorbidities precluding surgery
- Patients with implantable electromagnetic devices
- Pregnant women
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 |
|---|---|---|
| Wireless capsule endoscopywire less capsule endoscopy | Device | 1 |
| standard carestandard diagnostic evaluation as decided by treating physician | Other | 2 |
Primary outcome
sf36
Time frame: 48 weeks
giqli
Time frame: 48 weeks
eq50
Time frame: 48 weeks
diagnostic yield
Time frame: 48 weeks
1 secondary outcome
transfusions
Time frame: 48 weeks
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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RecruitingObservational study
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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.
Robert J Hilsden, 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 Wireless capsule endoscopy in people with Obscure Gastrointestinal Bleeding, 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 5 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?
sf36 (time frame: 48 weeks). The study lists 4 primary outcomes in all. 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.