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Emergency Capsule Endoscopy in Severe GI-bleeding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01584869
First Posted: April 25, 2012
Last Update Posted: January 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
  Purpose
Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding.

Condition Intervention Phase
GI-bleeding Device: capsule endoscopy Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • frequency of mid-GI-bleeding in all patients
  • diagnostic yield [ Time Frame: after complete recruitment ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584869


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01584869     History of Changes
Other Study ID Numbers: 23042012
First Submitted: April 23, 2012
First Posted: April 25, 2012
Last Update Posted: January 29, 2015
Last Verified: January 2015

Keywords provided by Technische Universität München:
GI-bleeding
capsule endoscopy

Additional relevant MeSH terms:
Emergencies
Hemorrhage
Gastrointestinal Hemorrhage
Disease Attributes
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases