Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00430664
Other study ID # 7134-PG-1Tg-05/5469-71
Secondary ID
Status Recruiting
Phase N/A
First received February 1, 2007
Last updated February 1, 2007
Start date January 2006
Est. completion date December 2007

Study information

Verified date February 2007
Source Postgraduate Institute of Medical Education and Research
Contact n/a
Is FDA regulated No
Health authority India: Institute Ethics Comittee, PGIMER Chandigarh
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Pleurodesis with either talc or iodopovidone


Locations

Country Name City State
India PGIMER Chandigarh

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success
Primary Failure
Secondary Death
Secondary Pain by VAS
Secondary Time to Pleurodesis
Secondary Others
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04831554 - Which is Better Between Single Chest Tube and Multiple Tubes Drainage in Primary Spontaneous Pneumothorax N/A
Recruiting NCT06411431 - Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial N/A
Completed NCT02109510 - Comparative Study of Nonintubated Anesthesia Versus Intubated General Anesthesia in Single Port Thoracoscopic Bullectomy N/A
Completed NCT00615849 - Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax Phase 3
Completed NCT03634605 - Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence N/A
Recruiting NCT06413966 - Study Compares Pneumothorax Recurrence: Absorbable Mesh vs. Pleurectomy in Primary Spontaneous Pneumothorax. N/A
Recruiting NCT02866305 - Study Designed to Optimize the Treatment of Primary Pneumothorax Phase 0
Recruiting NCT06088901 - Autologous Blood Patch for Primary Spontaneous Pneumothorax N/A