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

Primary Purpose

Malignant Pleural Effusions, Recurrent Pleural Effusions, Primary Spontaneous Pneumothorax

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Pleurodesis with either talc or iodopovidone

About this trial

This is an interventional treatment trial for Malignant Pleural Effusions focused on measuring pleurodesis, talc, iodopovidone

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

PGIMERRecruiting

Outcomes

Primary Outcome Measures

Success

Failure

Secondary Outcome Measures

Death

Pain by VAS

Time to Pleurodesis

Others

Full Information

NCT ID

NCT00430664

First Posted

February 1, 2007

Last Updated

February 1, 2007

Sponsor

Postgraduate Institute of Medical Education and Research

1. Study Identification

Unique Protocol Identification Number

NCT00430664

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Postgraduate Institute of Medical Education and Research

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Pleural Effusions, Recurrent Pleural Effusions, Primary Spontaneous Pneumothorax, Secondary Spontaneous Pneumothorax

Keywords

pleurodesis, talc, iodopovidone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Pleurodesis with either talc or iodopovidone

Primary Outcome Measure Information:

Title

Success

Title

Failure

Secondary Outcome Measure Information:

Title

Death

Title

Pain by VAS

Title

Time to Pleurodesis

Title

Others

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dheeraj Gupta, MD, DM, FCCP

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

PGIMER

City

Chandigarh

ZIP/Postal Code

160 012

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abinash Paul, MD

Phone

91-9417745955

draspaul@yahoo.co.in

First Name & Middle Initial & Last Name & Degree

Ritesh Agarwal, MD DM

Phone

91- 9815799226

ritesh@indiachest.org

12. IPD Sharing Statement

Learn more about this trial

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

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