PleuritisNCT02288065
Predictive Factors and Outcome in Medical Thoracoscopy
An observational study of Pleuritis, run by KU Leuven at 1 site in Belgium.
Trial summary
Retrospective survey for factors predicting the outcome of medical thoracoscopy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleuritis
- What is being tested?
- sterile talc pleurodesis
- How many people
- 155 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pulmonary or extrathoracic malignancy
Who may be able to join
- progressive malignancy
- pleuritis
Who cannot join
- respiratory failure
- unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective survey for factors predicting the outcome of medical thoracoscopy
Read the detailed description
Retrospective survey for factors predicting the outcome of medical thoracoscopy in patients with malignant pleuritis
- Conditions
- Pleuritis
- Being tested
- sterile talc pleurodesis
- Medical subject headings
- Pleurisy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterile talc pleurodesisDrug
Also called medical thoracoscopy
medical thoracoscopy and talc pleurodesis. No specific device is studied.
| Study group | Role | What they receive |
|---|---|---|
| responders | amelioration of dyspnea radiological amelioration after sterile talc pleurodesis Receives: Drug: sterile talc pleurodesis | |
| failed intervention | unchanged symptoms and radiology after sterile talc pleurodesis Receives: Drug: sterile talc pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest X-ray
radiological resolution of pleuritis; 3 level severity grading (A, B, C, with C as worst grade)
Measured: 3 months
Secondary outcomes (1)
time interval
survival in months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PleuritisStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yserbyt Jonas, KU Leuven
- Investigators
- Jonas Yserbyt, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288065
- Sponsor's protocol ID
- S561430
- Status last verified
- Dec 2016
- First submitted
- 4 Nov 2014
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors and Outcome in Medical Thoracoscopy
- ClinicalTrials.gov ID
- NCT02288065
- Acronym / sponsor ID
- S561430
- Conditions
- Pleuritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- 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.
Retrospective survey for factors predicting the outcome of medical thoracoscopy
Detailed description
Retrospective survey for factors predicting the outcome of medical thoracoscopy in patients with malignant pleuritis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| responders | – | Drug: sterile talc pleurodesisamelioration of dyspnea radiological amelioration after sterile talc pleurodesis |
| failed intervention | – | Drug: sterile talc pleurodesisunchanged symptoms and radiology after sterile talc pleurodesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pulmonary or extrathoracic malignancy
Key inclusion criteria (2 listed)
- progressive malignancy
- pleuritis
Key exclusion criteria (2 listed)
- respiratory failure
- unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sterile talc pleurodesisAlso: medical thoracoscopymedical thoracoscopy and talc pleurodesis. No specific device is studied. | Drug | failed intervention, responders |
Primary outcome
Chest X-ray
Time frame: 3 months
radiological resolution of pleuritis; 3 level severity grading (A, B, C, with C as worst grade)
1 secondary outcome
time interval
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
Related trials for Pleuritis
RecruitingEarly Phase 1
Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
Pleuritis, Non-specific
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.
Jonas Yserbyt principal investigator
UZ Leuven
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 Pleuritis, run by KU Leuven at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 30 Dec 2016. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chest X-ray (time frame: 3 months). 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 30 Dec 2016; AzTrials last refreshed its copy on 6 Nov 2026.