Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe
Device: capsule endoscopy
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Full eligibility criteria for NCT01584869
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
patients with signs of severe GI-bleeding (with melena or dark bloody stool) and hemodynamic instability (defined as (pre)collapse or MAP < 80 mmHg or HR > 110) and/or drop of hemoglobin > 2g/dl/d and/or need of transfusion of minimum of 2 packed red cells
missing consent form, pregnancy, origin of bleeding found in upper GI-endoscopy (e.g. blood in the stomach, ulcer, varices with signs of bleeding, mallory-weiss-tear, Angiodysplasia
(with signs of bleeding), refluxesophagitis LA C or D) fresh bloody stool, known stenosis of the bowel, known site of bleeding, known inflammatory bowel disease
All locations for NCT01584869
Klinikum rechts der Isar
München, Bavaria, Germany, 81675
View full eligibility
Tris trial is registered with FDA with number: NCT01584869. The sponsor of the trial is Technische Universität München and it is looking for 20 volunteers for the current phase.
Official trial title: Emergency Capsule Endoscopy in Severe GI-bleeding
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