NCT00430664

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 2, 2007

Status Verified

February 1, 2007

First QC Date

February 1, 2007

Last Update Submit

February 1, 2007

Conditions

Malignant Pleural EffusionsRecurrent Pleural EffusionsPrimary Spontaneous PneumothoraxSecondary Spontaneous Pneumothorax

Keywords

pleurodesistalciodopovidone

Outcome Measures

Primary Outcomes (2)

  • Success

  • Failure

Secondary Outcomes (4)

  • Death

  • Pain by VAS

  • Time to Pleurodesis

  • Others

Interventions

Pleurodesis with either talc or iodopovidonePROCEDURE

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Life expectancy \<1 month
  • Unwilling to give consent
  • Empyema
  • ICTD drain output \>150 ml/d
  • Presence of an airleak

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, 160 012, India

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, MalignantPleural EffusionPneumothorax

Interventions

PleurodesisPovidone-Iodine

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsIodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Dheeraj Gupta, MD, DM, FCCP

    Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

January 1, 2006

Study Completion

December 1, 2007

Last Updated

February 2, 2007

Record last verified: 2007-02

Locations

IN(1)