Emergency Capsule Endoscopy in Severe GI-bleeding

This study is currently recruiting participants.
Verified March 2014 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01584869
First received: April 23, 2012
Last updated: March 30, 2014
Last verified: March 2014
  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: 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
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: capsule endoscopy Device: capsule endoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584869

Contacts
Contact: Christoph Schlag, MD 00498941402454 Christoph.Schlag@lrz.tum.de
Contact: Stefan von Delius, MD 00498941402454 stefan_ruckert@yahoo.de

Locations
Germany
Klinikum rechts der Isar Recruiting
München, Bavaria, Germany, 81675
Principal Investigator: Christoph Schlag, MD         
Sub-Investigator: Stefan von Delius, MD         
Sub-Investigator: Bruno Neu, MD         
Sub-Investigator: Sebastian Noe, MD         
Sponsors and Collaborators
Technische Universität München
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01584869     History of Changes
Other Study ID Numbers: 23042012
Study First Received: April 23, 2012
Last Updated: March 30, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 17, 2014