Emergency Capsule Endoscopy in Severe GI-bleeding

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Gastrointestinal Hemorrhage
Hemorrhage
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014