Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Emergency Capsule Endoscopy in Severe GI-bleeding

This study has been completed.
Information provided by (Responsible Party):
Technische Universität München Identifier:
First received: April 23, 2012
Last updated: January 28, 2015
Last verified: January 2015

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

Condition Intervention Phase
Device: capsule endoscopy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Emergency Capsule Endoscopy in Severe GI-bleeding

Resource links provided by NLM:

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures. [ Time Frame: after complete recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequency of mid-GI-bleeding in all patients [ Designated as safety issue: No ]
  • diagnostic yield [ Time Frame: after complete recruitment ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: capsule endoscopy Device: capsule endoscopy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT01584869

Klinikum rechts der Isar
München, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
  More Information

No publications provided

Responsible Party: Technische Universität München Identifier: NCT01584869     History of Changes
Other Study ID Numbers: 23042012
Study First Received: April 23, 2012
Last Updated: January 28, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
capsule endoscopy

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes processed this record on February 25, 2015