Emergency Capsule Endoscopy in Severe GI-bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-03-31

Brief Summary

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

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Detailed Description

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Conditions

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GI-bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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capsule endoscopy

Group Type EXPERIMENTAL

capsule endoscopy

Intervention Type DEVICE

Interventions

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capsule endoscopy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No