- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01584869
Emergency Capsule Endoscopy in Severe GI-bleeding
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Bavaria
-
München, Bavaria, Germany, 81675
- Klinikum rechts der Isar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: capsule endoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.
Time Frame: after complete recruitment
|
after complete recruitment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
frequency of mid-GI-bleeding in all patients
|
|
diagnostic yield
Time Frame: after complete recruitment
|
after complete recruitment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23042012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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