NCT02288065

Brief Summary

Retrospective survey for factors predicting the outcome of medical thoracoscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

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

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

November 4, 2014

Last Update Submit

December 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chest X-ray

    radiological resolution of pleuritis; 3 level severity grading (A, B, C, with C as worst grade)

    3 months

Secondary Outcomes (1)

  • time interval

    12 months

Study Arms (2)

responders

amelioration of dyspnea radiological amelioration after sterile talc pleurodesis

Drug: sterile talc pleurodesis

failed intervention

unchanged symptoms and radiology after sterile talc pleurodesis

Drug: sterile talc pleurodesis

Interventions

medical thoracoscopy and talc pleurodesis. No specific device is studied.

Also known as: medical thoracoscopy
failed interventionresponders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pulmonary or extrathoracic malignancy

You may qualify if:

  • progressive malignancy
  • pleuritis

You may not qualify if:

  • respiratory failure
  • unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Pleurisy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPleural DiseasesRespiratory Tract Diseases

Study Officials

  • Jonas Yserbyt

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 11, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations