Malignant Pleural EffusionsNCT00430664
A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis
A study testing Pleurodesis with either talc or iodopovidone in people with Malignant Pleural Effusions and Recurrent Pleural Effusions, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Malignant Pleural Effusions, Recurrent Pleural Effusions, Primary Spontaneous Pneumothorax
- What is being tested?
- Pleurodesis with either talc or iodopovidone
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age over 12 years
- Symptomatic recurrent pleural effusion
- Pneumothorax needing pleurodesis
Who cannot join
- Life expectancy <1 month
- Unwilling to give consent
- Empyema
- ICTD drain output >150 ml/d
- Presence of an airleak
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, 160 012
Abinash Paul, MD, 91-9417745955, draspaul@yahoo.co.in
Ritesh Agarwal, MD DM, 91- 9815799226, ritesh@indiachest.org
About this study
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.
Read the 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.
- Conditions
- Malignant Pleural Effusions, Recurrent Pleural Effusions, Primary Spontaneous Pneumothorax, Secondary Spontaneous Pneumothorax
- Being tested
- Pleurodesis with either talc or iodopovidone
- Keywords
- pleurodesis, talc, iodopovidone
- Medical subject headings
- Pleural Effusion, Malignant, Pleural Effusion, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleurodesis with either talc or iodopovidoneProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
Failure
Secondary outcomes (4)
Death
Pain by VAS
Time to Pleurodesis
Others
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startJan 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- Dheeraj Gupta, MD, DM, FCCP, Principal investigator, Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430664
- Sponsor's protocol ID
- 7134-PG-1Tg-05/5469-71
- Status last verified
- Feb 2007
- First submitted
- 1 Feb 2007
- Last updated
- 2 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis
- ClinicalTrials.gov ID
- NCT00430664
- Acronym / sponsor ID
- 7134-PG-1Tg-05/5469-71
- Conditions
- Malignant Pleural Effusions, Recurrent Pleural Effusions, Primary Spontaneous Pneumothorax, Secondary Spontaneous Pneumothorax
- Keywords
- pleurodesis, talc, iodopovidone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2007
- First posted
- 2 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 12 years
- Symptomatic recurrent pleural effusion
- Pneumothorax needing pleurodesis
Key exclusion criteria (5 listed)
- Life expectancy <1 month
- Unwilling to give consent
- Empyema
- ICTD drain output >150 ml/d
- Presence of an airleak
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleurodesis with either talc or iodopovidone | Procedure or surgery | – |
Primary outcome
Success
Failure
4 secondary outcomes
Death
Pain by VAS
Time to Pleurodesis
Others
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dheeraj Gupta, MD, DM, FCCP principal investigator
Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleurodesis with either talc or iodopovidone in people with Malignant Pleural Effusions and Recurrent Pleural Effusions, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2007.