An observational study in GastroIntestinal Bleeding, sponsored by University Hospital Freiburg. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University Hospital Freiburg · Observational
Small bowel capsule endoscopy is the main diagnostic standard for small bowel bleeding. This study investigates the detection rate of small bowel bleeding in capsule endoscopy and further endoscopic treatment in a prospective and retrospective cohort.
Small bowel capsule endoscopy is considered the diagnostic gold standard in the diagnosis of diseases of the small bowel. Most indications for capsule endoscopy are overt small bowel bleedings - defined as gastrointestinal bleeding after negative gastroscopy and colonoscopy - or occult iron deficiency anemia. Timing of small bowel capsule endoscopy seems to be decisive for the diagnosis of small bowel bleeding: corresponding to the actual guidelines the detection of small bowel bleeding can be up to > 70% if the intervention is performed within 2 days. Treatment of small bowel bleedings can be performed with small bowel enteroscopy such as balloon or motorized spiral enteroscopy. Against this background this study investigates the rate of small bowel bleeding diagnosed in capsule endoscopy. The aim of the study is to report tumorous, vascular and inflammatory findings as well as complications and cecal accessibility. One focus of the study is the time between small bowel bleeding and small bowel capsule endoscopy and small bowel enteroscopy, respectively. Endoscopic therapies and further bleeding episodes are recorded. In order to determine the improved clinical outcome after the introduction of the shortened timing for recommendation published in 2022, a retrospective cohort should be included in addition to a prospective cohort.
338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 176 across 117 observational studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →University Hospital Freiburg is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who present with gastrointestinal bleeding undetected in gastroscopy or colonoscopy will be included in this cohort study. In these patients bleeding in the small bowel is suspected and they are allocated to a diagnostic assessment with small bowel capsule endoscopy.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gastrointestinal bleeding in the small bowel.
Device: Small bowel capsule endoscopy
Patients with gastrointestinal bleeding receive small bowel capsule endoscopy after bleeding could not be located in gastroscopy or colonoscopy.
Prevalence of small bowel bleeding detected during small bowel capsule endoscopy
Detection of bleeding during small bowel capsule endoscopy
Time frame: Through study completion, an average of 1 year
Prevalence of vascular lesions as source of bleeding
Detection of vascular lesions angiodysplasia) as source of bleeding
Time frame: Through study completion, an average of 1 year
Prevalence of inflammatory lesions as source of bleeding
Detection of inflammatory lesions as source of bleeding
Time frame: Through study completion, an average of 1 year
Prevalence of tumor lesions as source of bleeding
Detection of tumor lesions as source of bleeding
Time frame: Through study completion, an average of 1 year
Complications of small bowel capsule endoscopy
Complications of small bowel capsule endoscopy
Time frame: Through study completion, an average of 1 year
Technical success of small bowel capsule endoscopy
Technical success is defined as arrival of the capsule in the cecum
Time frame: Through study completion, an average of 1 year
Time between diagnostic small bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding
Time between diagnostic mall bowel capsule endoscopy and small bowel enteroscopy for treatment of bleeding
Time frame: From time to the end of capsule endoscopy until beginning of small bowel enteroscopy
Plan to share: No — IPD are shared on reasonable request to the Principal Investigator.
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University Hospital Freiburg