Empyema Thoracis in ChildrenNCT04177550
Early Results of Empyema Thoracis Treatment in Children by Video-assisted Thoracoscopic Surgery
An observational study of Empyema Thoracis in Children, run by Nhan Pham Nguyen Hien at 1 site in Vietnam.
Trial summary
The aim of study is to assess early results of Empyema Thoracis treatment in Children by Video-assisted Thoracoscopic Surgery Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Empyema Thoracis in Children
- How many people
- 44 participants
- Where
- 1 siteVietnam
- Study dates
- 21 Dec 2019to 21 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- 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.
Who cannot join
- The patient had empyema caused by Tuberculosis.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of study is to assess early results of Empyema Thoracis treatment in Children by Video-assisted Thoracoscopic Surgery
- Conditions
- Empyema Thoracis in Children
- Keywords
- empyema thoracis, Thoracoscopic, VATS, Video-assisted Thoracoscopic Surgery, Pediatric Empyema Thoracis
- Medical subject headings
- Empyema
What is being measured
The primary outcome is the main question the study is designed to answer.
Recover
Time of operation
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start21 Dec 2019 (estimated)
- Primary completion21 Dec 2019 (estimated)
- Study completion21 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Empyema Thoracis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nhan Pham Nguyen Hien
- Sponsor type
- University, hospital or other
- Collaborators
- Ho Trung Cuong, Trinh Nguyen Ha Vi, Tran Nhu Quynh, Vu Minh Thuy, Nguyen Thi Tuong Lam
- Responsible party
- Sponsor-investigator, Nhan Pham Nguyen Hien, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177550
- Sponsor's protocol ID
- NT 62 72 07 35
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will decide when the research is complete
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Results of Empyema Thoracis Treatment in Children by Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT04177550
- Acronym / sponsor ID
- NT 62 72 07 35
- Conditions
- Empyema Thoracis in Children
- Keywords
- empyema thoracis, Thoracoscopic, VATS, Video-assisted Thoracoscopic Surgery, Pediatric Empyema Thoracis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Nhan Pham Nguyen HienUniversity, hospital or other
- Collaborators
- Ho Trung Cuong, Trinh Nguyen Ha Vi, Tran Nhu Quynh, Vu Minh Thuy, Nguyen Thi Tuong Lam
- Study start
- 21 Dec 2019 (estimated)
- Primary completion
- 21 Dec 2019 (estimated)
- Study completion
- 21 May 2020 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study is to assess early results of Empyema Thoracis treatment in Children by Video-assisted Thoracoscopic Surgery
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The patient had empyema caused by Tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recover
Time frame: 2 hours
Time of operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: Undecided. We will decide when the research is complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Empyema Thoracis in Children, run by Nhan Pham Nguyen Hien at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recover (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.