Early Results of Empyema Thoracis Treatment in Children b... | NCT04177550

Studies
Early Results of Empyema Thoracis Treatment in Children by Video-assisted Thoracoscopic Surgery

NCT04177550

Sponsor

Nhan Pham Nguyen Hien

Status

Unknown status

Last Update Posted

Nov 29, 2019Actual

Enrollment

44Estimated

Phase

Not provided

Conditions

Empyema Thoracis in Children

Interventions

Not provided

Countries

Vietnam

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2019Estimated

Primary Completion Date

Dec 21, 2019Estimated

Completion Date

May 21, 2020Estimated

First Submitted Date

Nov 24, 2019

First Submission Date that Met QC Criteria

Nov 24, 2019

First Posted Date

Nov 26, 2019Actual

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

Nov 26, 2019

Last Update Posted Date

Nov 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nhan Pham Nguyen Hien, Principal Investigator, University of Medicine and Pharmacy at Ho Chi Minh CitySponsor-Investigator

Lead Sponsor

Nhan Pham Nguyen HienOTHER

Collaborators

Name	Class
Ho Trung Cuong	UNKNOWN
Trinh Nguyen Ha Vi	UNKNOWN
Tran Nhu Quynh	UNKNOWN
Vu Minh Thuy

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of study is to assess early results of Empyema Thoracis treatment in Children by Video-assisted Thoracoscopic Surgery

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recover	Time of operation	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients had empyema.
All patients had been treated by Video-assisted Thoracoscopic Surgery in Children hospital 1 from 01/01/2015 to 30/04/2019.

Exclusion Criteria:

The patient had empyema caused by Tuberculosis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

The patient had empyema who treated by Video-assisted Thoracoscopic Surgery in Children hospital 1 from 01/01/2015 to 30/04/2019

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children hospital no.1		Ho Chi Minh City			Vietnam

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

We will decide when the research is complete

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004653	Empyema

Ancestor Terms

ID	Term
D013492	Suppuration
D007239	Infections
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided