UnknownNot Applicable

Assessing Depth of Small Bowel Insertion at Push Enteroscopy by Using Capsule Endoscopy

Canada59 participantsStarted 2019-07-01

Plain-language summary

Bleeding from the gastrointestinal tract can originate from the small bowel. Typically, upper and lower endoscopies are unable to identify the site of bleeding and patients need to undergo special endoscopies with longer cameras to examine the small bowel and find the bleeding site. One of the most commonly used scopes to investigate the first part of the small intestinal is called "push enteroscopy". This is an upper endoscopy that uses a pediatric colonoscope, which is longer. To date, it is unknown what percentage of small bowel can be observed with this technique. Hence, this study aimed to determine the extent of small bowel examined by push enteroscopy. Consecutive patients with suspected bleeding from the small intestine will undergo a push enteroscopy and the depth of the examination will be marked with metallic clips. Subsequently, patients will have a capsule endoscopy, which is a little camera that will take multiple pictures of the whole small intestine. The percentage of small bowel that the push enteroscopy examined will be determined by the percentage of small bowel corresponding to the location of the clips visualized on capsule endoscopy.

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: * Patients with overt signs of GI bleeding (OGIB) (hematochezia or melena with an associated drop in hemoglobin) or occult signs of GI bleeding in the form of persistent or recurrent iron deficiency anemia and had undergone esophagogastroduodenoscopy (EGD) and colonoscopy that were negative for a source of bleeding. Exclusion Criteria: * Significant cardiopulmonary disease, an implanted electromedical device, pregnancy, previous gastrectomy, extensive Crohn's disease with suspicion for stricturing or fistulizing small bowel disease

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?

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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

Percentage of small bowel examination

Timeframe: through study completion, an average of 3 years

Trial details

NCT IDNCT05731388

SponsorUnity Health Toronto

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Obscure Gastrointestinal Bleeding trials