Emergency Capsule Endoscopy in Severe GI-bleeding

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01584869

Enrollment

Registered

2012-04-25

Start date

2011-12-31

Completion date

2014-03-31

Last updated

2015-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GI-bleeding

Keywords

GI-bleeding, capsule endoscopy

Brief summary

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

Interventions

DEVICEcapsule endoscopy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.	after complete recruitment

Secondary

Measure	Time frame
frequency of mid-GI-bleeding in all patients	—
diagnostic yield	after complete recruitment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026