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A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430664
First Posted: February 2, 2007
Last Update Posted: February 2, 2007
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.
Information provided by:
Postgraduate Institute of Medical Education and Research
  Purpose
Pleurodesis is a technique used to fuse the two layers of the lining over the lung. This is done to get rid of collections of fluid or air in this space. A common reason would be cancer of the underlying lung or elsewhere causing fluid to collect in the pleural space. In this situation it is a palliative procedure to free the patient from symptoms like breathlessness.

Condition Intervention
Malignant Pleural Effusions Recurrent Pleural Effusions Primary Spontaneous Pneumothorax Secondary Spontaneous Pneumothorax Procedure: Pleurodesis with either talc or iodopovidone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Success
  • Failure

Secondary Outcome Measures:
  • Death
  • Pain by VAS
  • Time to Pleurodesis
  • Others

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Study Completion Date: December 2007
Detailed Description:
Pleurodesis is a technique used to fuse the two layers of the pleura. This is done to prevent reaccumulation of collections of fluid or air in this space. Common indications are malignant pleural effusions, recurrent pneumothorax and even benign effusions which are otherwise difficult to eradicate.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 12 years
  • Symptomatic recurrent pleural effusion
  • Pneumothorax needing pleurodesis

Exclusion Criteria:

  • Life expectancy <1 month
  • Unwilling to give consent
  • Empyema
  • ICTD drain output >150 ml/d
  • Presence of an airleak
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430664


Locations
India
PGIMER Recruiting
Chandigarh, India, 160 012
Contact: Abinash Paul, MD    91-9417745955    draspaul@yahoo.co.in   
Contact: Ritesh Agarwal, MD DM    91- 9815799226    ritesh@indiachest.org   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Dheeraj Gupta, MD, DM, FCCP Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India
  More Information

ClinicalTrials.gov Identifier: NCT00430664     History of Changes
Other Study ID Numbers: 7134-PG-1Tg-05/5469-71
First Submitted: February 1, 2007
First Posted: February 2, 2007
Last Update Posted: February 2, 2007
Last Verified: February 2007

Keywords provided by Postgraduate Institute of Medical Education and Research:
pleurodesis
talc
iodopovidone

Additional relevant MeSH terms:
Pleural Effusion
Pneumothorax
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms