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Predictive Factors and Outcome in Medical Thoracoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02288065
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Yserbyt Jonas, KU Leuven

Tracking Information
First Submitted Date November 4, 2014
First Posted Date November 11, 2014
Last Update Posted Date December 30, 2016
Study Start Date January 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2014)
Chest X-ray [ Time Frame: 3 months ]
radiological resolution of pleuritis; 3 level severity grading (A, B, C, with C as worst grade)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 7, 2014)
time interval [ Time Frame: 12 months ]
survival in months
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictive Factors and Outcome in Medical Thoracoscopy
Official Title Predictive Factors and Outcome in Medical Thoracoscopy
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population pulmonary or extrathoracic malignancy
Condition Pleuritis
Intervention Drug: sterile talc pleurodesis
medical thoracoscopy and talc pleurodesis. No specific device is studied.
Other Name: medical thoracoscopy
Study Groups/Cohorts
  • responders
    amelioration of dyspnea radiological amelioration after sterile talc pleurodesis
    Intervention: Drug: sterile talc pleurodesis
  • failed intervention
    unchanged symptoms and radiology after sterile talc pleurodesis
    Intervention: Drug: sterile talc pleurodesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 29, 2016)
155
Original Estimated Enrollment
 (submitted: November 7, 2014)
200
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • progressive malignancy
  • pleuritis

Exclusion Criteria:

  • respiratory failure
  • unable to consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02288065
Other Study ID Numbers S561430
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yserbyt Jonas, KU Leuven
Study Sponsor KU Leuven
Collaborators Not Provided
Investigators
Principal Investigator: Jonas Yserbyt UZ Leuven
PRS Account KU Leuven
Verification Date December 2016