CompletedNot Applicable

Capsule Endoscopy in Obscure GI Bleeding

Canada40 participantsStarted 2005-05

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

sf36

Timeframe: 48 weeks

giqli

Timeframe: 48 weeks

eq50

Timeframe: 48 weeks

diagnostic yield

Timeframe: 48 weeks

Trial details

NCT IDNCT00203619

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Obscure Gastrointestinal Bleeding trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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