Actively Recruiting
Led by University Hospital Freiburg · Updated on 2026-05-01
1300
Participants Needed
1
Research Sites
28 weeks
Total Duration
Researchers are investigating the detection rate of small bowel bleeding using small bowel capsule endoscopy, which is the current gold standard for diagnosing small bowel diseases. The study focuses on patients with gastrointestinal bleeding that remains undetected by gastroscopy and colonoscopy. It aims to assess findings such as tumorous, vascular, and inflammatory lesions, as well as complications and the ability to reach the cecum. The study also examines the timing between bleeding episodes and the performance of capsule endoscopy and further endoscopic treatments. Participants with suspected small bowel bleeding will undergo small bowel capsule endoscopy, a device-based procedure to detect bleeding sources. If bleeding is identified, further treatment may be performed using small bowel enteroscopy techniques like balloon or motorized spiral enteroscopy. The study includes both prospective and retrospective cohorts to evaluate outcomes before and after a new guideline recommending earlier intervention within two days of bleeding. During the study, researchers will track the prevalence of small bowel bleeding and specific lesion types, monitor any complications, and assess the technical success of the capsule endoscopy procedure. They will also measure the time interval between the diagnostic capsule endoscopy and the subsequent enteroscopy treatment. Participant involvement includes follow-up for about one year to observe bleeding episodes and treatment outcomes, with data collected on safety and effectiveness of the procedures.
CONDITIONS
Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 days from bleeding event to capsule endoscopy
Participants undergo small bowel capsule endoscopy to detect gastrointestinal bleeding after negative gastroscopy and colonoscopy.
1 visit (in-person)
Duration - Up to 1 year
Participants are followed to record findings, complications, and clinical outcomes for up to 1 year after capsule endoscopy.
Follow-up visits as needed during the year
Total: 1 location
1
University Medical Center Freiburg, Department of Medicine II
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
M
Michael Schultheiss, MD
D
Dominik Bettinger, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Emanuele Rondonotti, Cristiano Spada, Samuel Adler...
https://pubmed.ncbi.nlm.nih.gov/29539652