Pleural EffusionPhase 4NCT02975921
Betadine Pleurodesis Via Tunneled Pleural Catheters
A Phase 4 study testing Povidone-Iodine in people with Pleural Effusion and Pleurodesis, run by Yale University.
Trial summary
The purpose of this study is to determine whether betadine (povidone-iodine) instillation during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in promoting pleurodesis and thus reducing the time to TPC removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Pleurodesis, Malignant Pleural Effusion
- What is being tested?
- Povidone-Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jun 2021
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requiring Tunneled Catheter Placement for a Pleural Effusion
Who cannot join
- Patient with a nonexpandable lung
- Non-english speaker
About this study
Official title: Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial
The purpose of this study is to determine whether betadine (povidone-iodine) instillation during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in promoting pleurodesis and thus reducing the time to TPC removal.
Read the detailed description
Tunneled pleural catheter (TPC) placement is a routine clinical procedure used in the setting of recurrent pleural effusions. The most common clinical indication is malignant pleural effusion but these can be used in benign pleural effusions as well (such as those due to congestive heart failure, cirrhosis, etc). The primary benefit of TPC placement is relief of dyspnea without the need for recurrent procedures.
Despite success at relieving dyspnea, there are problems with the long-term placement of TPC's. One risk is infection which is estimated at 5%. Furthermore, each drainage kit costs approximately $100 and is often paid out-of-pocket by patients. Over time, this may create a substantial cost burden. Finally, most patients who undergo TPC placement require home drainage by visiting nurses. This is a significant resource utilization and it often requires interruption of a patient's home routines via the visitation requirements.
Occasionally, the effusion no longer reaccumulates following TPC placement. In malignant effusions, this pleurodesis (see below) occurs up to 50% of the time in malignant effusions. When pleurodesis occurs, the TPC may be removed by a simple office procedure.
Pleurodesis, or the act of inducing scarring and obliteration of the potential space between the visceral and parietal pleura where pleural effusions develop, is a different mechanism of providing relief of dyspnea. In the USA in particular, the most common agent used for pleurodesis (talc) is associated with complications such as respiratory failure and adult respiratory distress syndrome (ARDS), a life-threatening condition. Talc is also very expensive.
Povidone-Iodine, an agent used for pleurodesis in many other countries, has been shown to be highly efficacious when given via other modalities. Studies report a pleurodesis rate of 90+% with Povidone-Iodine. It also has a favorable safety record and is inexpensive.
Given all of these factors, the investigators propose a prospective study using Povidone-Iodine at the time of TPC placement to promote pleurodesis. The investigators hypothesize that pleurodesis will occur quickly and frequently, thus enabling removal of the TPC, thereby saving cost, risks of infection, all while improving patients quality of life.
The investigators plan on doing this by enrolling patients prospectively who are to undergo TPC placement as part of their standard care. These patients would be prospectively enrolled and randomized to receive either usual care (no pleurodesis) or the investigational medication (povidone-iodine) intrapleurally at time of procedure. The investigators would subdivide groups prospectively between patients who have malignant pleural effusions and those who have benign (non-malignant) pleural effusions.
Following TPC placement and medication administration (if necessary), nursing and investigative physicians would then immediately follow them in the recovery area (to monitor for any negative immediate outcomes such as hypertension, hypotension, reactions, or significant pain) and in clinic as per their usual care (starting 1-2 weeks after discharge and as long as necessary). The investigators would monitor them for the outcomes as noted elsewhere.
- Conditions
- Pleural Effusion, Pleurodesis, Malignant Pleural Effusion, Pleural Effusion Due to Congestive Heart Failure, Pleural Effusion in Conditions Classified Elsewhere, Pleural Effusions, Chronic
- Being tested
- Povidone-Iodine
- Keywords
- Pleural Effusion, Thoracentesis, Pleural Cavity, Pleurodesis, Tunneled Pleural Catheter
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called Betadine
Intrapleural administration of Povidone-Iodine
| Study group | Role | What they receive |
|---|---|---|
| Malignant Effusion - Usual Care | No intervention | Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly. |
| Malignant Effusion with Pleurodesis | Experimental | Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly. Receives: Drug: Povidone-Iodine |
| Benign Effusion - Usual Care | No intervention | Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly. |
| Benign Effusion with Pleurodesis | Experimental | Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly. Receives: Drug: Povidone-Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tunneled Pleural Catheter Removal
The time (in days) between Tunneled Pleural Catheter (TPC) placement to eventual removal within 6 months
Measured: 0-6 months
Secondary outcomes (18)
Pleurodesis Rate
Rate of patients who achieved successful pleurodesis within 2 months as defined as successful TPC removal with no reaccumulation of pleural effusion on subsequent imaging (usually 2-3 weeks later). Typical for usual care is 45-50%. In observational studies using povidone-iodine pleurodesis in other manners (not via TPC), a 90% pleurodesis rate was observed (which should be similar to our study with intervention).
Measured: 2 months
Infection Rate
Any skin/site infections or empyemas (pleural based infections) noted within 6 months of TPC placement. The longer a TPC is in place, the higher the rate of infection we would expect. The expected infection rate is between 5-25% at 2 months and this should be dramatically lower in the intervention arm as most of them will have their TPCs removed within 1 week or so.
Measured: 6 months
Death
Any deaths that occur and how long after TPC placement and the patients age at death. As patients are quite systemically ill when they receive TPCs, these comorbidities would be expected to be the primary drivers of patient mortality. Typical values seen in the literature is a mortality rate of 30-70% at 6 months. There should be essentially no difference between groups.
Measured: 6 months
Mechanical Complications
Any mechanical complications related to the TPC itself such as catheter malfunction or accidental removal. This would be a rare complication and the expected rate will be <5%. The incidence of this will rise the longer it is in place for.
Measured: 6 months
Baseline Borg Dyspnea Index
The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured at baseline prior to Tunneled Pleural Catheter Placement.
Measured: Baseline
Borg Dyspnea Index at 2 weeks
The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 2 weeks after tunneled pleural catheter placement.
Measured: 2 weeks
Borg Dyspnea Index at 2 months
The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 2 months after tunneled pleural catheter placement.
Measured: 2 months
Borg Dyspnea Index at 4 months
The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 4 months after tunneled pleural catheter placement.
Measured: 4 months
Borg Dyspnea Index at 6 months
The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 6 months after tunneled pleural catheter placement.
Measured: 6 months
Quality of Life Questionnaire at Baseline
Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured at baseline prior to the procedure.
Measured: Baseline
Quality of Life Questionnaire at 2 weeks
Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 2 weeks after TPC placement.
Measured: 2 weeks
Quality of Life Questionnaire at 2 months
Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 2 months after TPC placement.
Measured: 2 months
Quality of Life Questionnaire at 4 months
Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 4 months after TPC placement.
Measured: 4 months
Quality of Life Questionnaire at 6 months
Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 6 months after TPC placement.
Measured: 6 months
Baseline Pain
Pain at baseline - immediately prior to procedure.
Measured: Baseline
Pain 2 hours after procedure
Pain at 2 hours after the procedure.
Measured: 2 hours after procedure
Pain 6 hours after procedure
Pain at 6 hours after the procedure.
Measured: 6 hours after procedure
Immediate hemodynamic reactions following betadine administration
Any severe hemodynamic fluctuations (such as severe hypotension or hypertension) noted after the procedure. The patient will monitored by nursing staff in a recovery area and any events will be noted immediately. The expected rate of this is <5%.
Measured: 0-6 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJul 2018 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: The site decided not to proceed with the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan T Puchalski, MD, MEd, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975921
- Sponsor's protocol ID
- 2000020017
- Status last verified
- Jan 2019
- First submitted
- 17 Nov 2016
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agarwal R, Khan A, Aggarwal AN, Gupta D. Efficacy & safety of iodopovidone pleurodesis: a systematic review & meta-analysis. Indian J Med Res. 2012 Mar;135(3):297-304.
PubMed 22561614Ahmed L, Ip H, Rao D, Patel N, Noorzad F. Talc pleurodesis through indwelling pleural catheters for malignant pleural effusions: retrospective case series of a novel clinical pathway. Chest. 2014 Dec;146(6):e190-e194. doi: 10.1378/chest.14-0394.
PubMed 25451360Hak CC, Sivakumar P, Ahmed L. Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. BMC Pulm Med. 2016 Mar 11;16:41. doi: 10.1186/s12890-016-0203-7.
PubMed 26968653Light RW. Pleural effusions. Med Clin North Am. 2011 Nov;95(6):1055-70. doi: 10.1016/j.mcna.2011.08.005. Epub 2011 Sep 25.
PubMed 22032427Penz ED, Mishra EK, Davies HE, Manns BJ, Miller RF, Rahman NM. Comparing cost of indwelling pleural catheter vs talc pleurodesis for malignant pleural effusion. Chest. 2014 Oct;146(4):991-1000. doi: 10.1378/chest.13-2481.
PubMed 24832000Van Meter ME, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med. 2011 Jan;26(1):70-6. doi: 10.1007/s11606-010-1472-0. Epub 2010 Aug 10.
PubMed 20697963Walker S, Bibby AC, Maskell NA. Current best practice in the evaluation and management of malignant pleural effusions. Ther Adv Respir Dis. 2017 Feb;11(2):105-114. doi: 10.1177/1753465816671697. Epub 2016 Oct 24.
PubMed 27777372
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02975921
- Acronym / sponsor ID
- 2000020017
- Conditions
- Pleural Effusion, Pleurodesis, Malignant Pleural Effusion, Pleural Effusion Due to Congestive Heart Failure, Pleural Effusion in Conditions Classified Elsewhere, Pleural Effusions, Chronic
- Keywords
- Pleural Effusion, Thoracentesis, Pleural Cavity, Pleurodesis, Tunneled Pleural Catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The site decided not to proceed with the protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 Nov 2016 (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.
The purpose of this study is to determine whether betadine (povidone-iodine) instillation during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in promoting pleurodesis and thus reducing the time to TPC removal.
Detailed description
Tunneled pleural catheter (TPC) placement is a routine clinical procedure used in the setting of recurrent pleural effusions. The most common clinical indication is malignant pleural effusion but these can be used in benign pleural effusions as well (such as those due to congestive heart failure, cirrhosis, etc). The primary benefit of TPC placement is relief of dyspnea without the need for recurrent procedures.
Despite success at relieving dyspnea, there are problems with the long-term placement of TPC's. One risk is infection which is estimated at 5%. Furthermore, each drainage kit costs approximately $100 and is often paid out-of-pocket by patients. Over time, this may create a substantial cost burden. Finally, most patients who undergo TPC placement require home drainage by visiting nurses. This is a significant resource utilization and it often requires interruption of a patient's home routines via the visitation requirements.
Occasionally, the effusion no longer reaccumulates following TPC placement. In malignant effusions, this pleurodesis (see below) occurs up to 50% of the time in malignant effusions. When pleurodesis occurs, the TPC may be removed by a simple office procedure.
Pleurodesis, or the act of inducing scarring and obliteration of the potential space between the visceral and parietal pleura where pleural effusions develop, is a different mechanism of providing relief of dyspnea. In the USA in particular, the most common agent used for pleurodesis (talc) is associated with complications such as respiratory failure and adult respiratory distress syndrome (ARDS), a life-threatening condition. Talc is also very expensive.
Povidone-Iodine, an agent used for pleurodesis in many other countries, has been shown to be highly efficacious when given via other modalities. Studies report a pleurodesis rate of 90+% with Povidone-Iodine. It also has a favorable safety record and is inexpensive.
Given all of these factors, the investigators propose a prospective study using Povidone-Iodine at the time of TPC placement to promote pleurodesis. The investigators hypothesize that pleurodesis will occur quickly and frequently, thus enabling removal of the TPC, thereby saving cost, risks of infection, all while improving patients quality of life.
The investigators plan on doing this by enrolling patients prospectively who are to undergo TPC placement as part of their standard care. These patients would be prospectively enrolled and randomized to receive either usual care (no pleurodesis) or the investigational medication (povidone-iodine) intrapleurally at time of procedure. The investigators would subdivide groups prospectively between patients who have malignant pleural effusions and those who have benign (non-malignant) pleural effusions.
Following TPC placement and medication administration (if necessary), nursing and investigative physicians would then immediately follow them in the recovery area (to monitor for any negative immediate outcomes such as hypertension, hypotension, reactions, or significant pain) and in clinic as per their usual care (starting 1-2 weeks after discharge and as long as necessary). The investigators would monitor them for the outcomes as noted elsewhere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Malignant Effusion - Usual Care | No intervention | –Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly. |
| Malignant Effusion with Pleurodesis | Experimental | Drug: Povidone-IodinePatients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly. |
| Benign Effusion - Usual Care | No intervention | –Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly. |
| Benign Effusion with Pleurodesis | Experimental | Drug: Povidone-IodinePatients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Requiring Tunneled Catheter Placement for a Pleural Effusion
Key exclusion criteria (2 listed)
- Patient with a nonexpandable lung
- Non-english speaker
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 |
|---|---|---|
| Povidone-IodineAlso: BetadineIntrapleural administration of Povidone-Iodine | Drug | Benign Effusion with Pleurodesis, Malignant Effusion with Pleurodesis |
Primary outcome
Time to Tunneled Pleural Catheter Removal
Time frame: 0-6 months
The time (in days) between Tunneled Pleural Catheter (TPC) placement to eventual removal within 6 months
18 secondary outcomes
Pleurodesis Rate
Time frame: 2 months
Infection Rate
Time frame: 6 months
Death
Time frame: 6 months
Mechanical Complications
Time frame: 6 months
Baseline Borg Dyspnea Index
Time frame: Baseline
Borg Dyspnea Index at 2 weeks
Time frame: 2 weeks
Borg Dyspnea Index at 2 months
Time frame: 2 months
Borg Dyspnea Index at 4 months
Time frame: 4 months
Borg Dyspnea Index at 6 months
Time frame: 6 months
Quality of Life Questionnaire at Baseline
Time frame: Baseline
Quality of Life Questionnaire at 2 weeks
Time frame: 2 weeks
Quality of Life Questionnaire at 2 months
Time frame: 2 months
Quality of Life Questionnaire at 4 months
Time frame: 4 months
Quality of Life Questionnaire at 6 months
Time frame: 6 months
Baseline Pain
Time frame: Baseline
Pain 2 hours after procedure
Time frame: 2 hours after procedure
Pain 6 hours after procedure
Time frame: 6 hours after procedure
Immediate hemodynamic reactions following betadine administration
Time frame: 0-6 hours after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Background: PubMed 22561614Agarwal R, Khan A, Aggarwal AN, Gupta D. Efficacy & safety of iodopovidone pleurodesis: a systematic review & meta-analysis. Indian J Med Res. 2012 Mar;135(3):297-304.
- Background: PubMed 25451360Ahmed L, Ip H, Rao D, Patel N, Noorzad F. Talc pleurodesis through indwelling pleural catheters for malignant pleural effusions: retrospective case series of a novel clinical pathway. Chest. 2014 Dec;146(6):e190-e194. doi: 10.1378/chest.14-0394.
- Background: PubMed 26968653Hak CC, Sivakumar P, Ahmed L. Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. BMC Pulm Med. 2016 Mar 11;16:41. doi: 10.1186/s12890-016-0203-7.
- Background: PubMed 22032427Light RW. Pleural effusions. Med Clin North Am. 2011 Nov;95(6):1055-70. doi: 10.1016/j.mcna.2011.08.005. Epub 2011 Sep 25.
- Background: PubMed 24832000Penz ED, Mishra EK, Davies HE, Manns BJ, Miller RF, Rahman NM. Comparing cost of indwelling pleural catheter vs talc pleurodesis for malignant pleural effusion. Chest. 2014 Oct;146(4):991-1000. doi: 10.1378/chest.13-2481.
- Background: PubMed 20697963Van Meter ME, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med. 2011 Jan;26(1):70-6. doi: 10.1007/s11606-010-1472-0. Epub 2010 Aug 10.
- Background: PubMed 27777372Walker S, Bibby AC, Maskell NA. Current best practice in the evaluation and management of malignant pleural effusions. Ther Adv Respir Dis. 2017 Feb;11(2):105-114. doi: 10.1177/1753465816671697. Epub 2016 Oct 24.
- Individual participant dataSharing planned: No
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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.
Jonathan T Puchalski, MD, MEd principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone-Iodine in people with Pleural Effusion and Pleurodesis, run by Yale University.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Tunneled Pleural Catheter Removal (time frame: 0-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975921, which also lists 7 linked publications.
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 11 Jan 2019.