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OpenTrials
Completed

NCT Number: NCT01584869

Emergency Capsule Endoscopy in Severe GI-bleeding

Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding.

Completed

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Key information

Conditions

GI-bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

capsule endoscopy

Device

Primary outcomes

  1. the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.

    Time frame: after complete recruitment

Secondary outcomes

  1. frequency of mid-GI-bleeding in all patients

  2. diagnostic yield

    Time frame: after complete recruitment

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2012
Registry last updated
Jan 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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