Emergency Capsule Endoscopy in Severe GI-bleeding

Technical University of Munich

Status and phase: Completed; Phase 3; Phase 2

Conditions: GI-bleeding

Treatments: Device: capsule endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01584869

23042012

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

capsule endoscopy

Experimental group

Treatment:

Device: capsule endoscopy