Emergency Capsule Endoscopy in Severe GI-bleeding | NCT01584869

Studies
Emergency Capsule Endoscopy in Severe GI-bleeding

NCT01584869

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Jan 29, 2015Estimated

Enrollment

20Estimated

Phase

Phase 2Phase 3

Conditions

GI-bleeding

Interventions

capsule endoscopy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Apr 23, 2012

First Submission Date that Met QC Criteria

Apr 24, 2012

First Posted Date

Apr 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2015

Last Update Posted Date

Jan 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
capsule endoscopy	Experimental		Device: capsule endoscopy

Name	Type	Description	Arm Group Labels	Other Names
capsule endoscopy	Device		capsule endoscopy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar		München	Bavaria	81675	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25432532	Derived	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.

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical