Emergency Capsule Endoscopy in Severe GI-bleeding

GI-bleeding Clinical Trial

Official title:

Emergency Capsule Endoscopy in Severe GI-bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584869
• Other study ID #: 23042012
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 23, 2012
• Last updated: January 28, 2015
• Start date: December 2011
• Est. completion date: March 2014

Study information

• Verified date: January 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• GI-bleeding
• Hemorrhage

Intervention

Device:
• capsule endoscopy

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.		after complete recruitment	No
Secondary	frequency of mid-GI-bleeding in all patients			No
Secondary	diagnostic yield		after complete recruitment	No