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Emergency Capsule Endoscopy in Severe GI-bleeding

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ClinicalTrials.gov Identifier: NCT01584869
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
GI-bleeding Device: capsule endoscopy Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Emergency Capsule Endoscopy in Severe GI-bleeding
Study Start Date : December 2011
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: capsule endoscopy Device: capsule endoscopy


Outcome Measures

Primary Outcome Measures :
  1. the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures. [ Time Frame: after complete recruitment ]

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

Eligibility Criteria

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 Posted: April 25, 2012    Key Record Dates
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