NCT01584869

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

April 23, 2012

Last Update Submit

January 28, 2015

Conditions

GI-bleeding

Keywords

GI-bleedingcapsule endoscopy

Outcome Measures

Primary Outcomes (1)

  • the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.

    after complete recruitment

Secondary Outcomes (2)

  • frequency of mid-GI-bleeding in all patients

  • diagnostic yield

    after complete recruitment

Study Arms (1)

capsule endoscopy

EXPERIMENTAL
Device: capsule endoscopy

Interventions

capsule endoscopyDEVICE
capsule endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

Location

Related Publications (1)

  • Schlag C, Menzel C, Nennstiel S, Neu B, Phillip V, Schuster T, Schmid RM, von Delius S. Emergency video capsule endoscopy in patients with acute severe GI bleeding and negative upper endoscopy results. Gastrointest Endosc. 2015 Apr;81(4):889-95. doi: 10.1016/j.gie.2014.09.035.

    PMID: 25432532DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations

DE(1)