Pleura; EffusionNCT03550027
Indwelling Pleural Catheter for Trapped Lung
A study testing PleurX and Pleurocath in people with Pleura; Effusion, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleura; Effusion
- What is being tested?
- PleurX and Pleurocath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2017to 15 Feb 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible)
Who cannot join
- - Age younger than 18 years
- Expected survival of less than 3 months
- Chylothorax
- Total white blood cell count less than 1000/microL
- Pregnancy or lactating mothers
- Irreversible bleeding diathesis
Show all 10Show fewer
- Irreversible visual impairment
- Contraindications to general anesthesia
- Poor general clinical conditions ( ECOG PS >=2)
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indwelling Pleural Catheter for Trapped Lung: a Pilot Study for Power Calculation of a Randomized Controlled Trial Comparing Pleurocath® Versus PleurX®)
Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL).
The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.
- Conditions
- Pleura; Effusion
- Being tested
- PleurX, Pleurocath
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PleurXDevice
Positioning of drainage PleurX
PleurocathDevice
Positioning of drainage Pleurocath
| Study group | Role | What they receive |
|---|---|---|
| PleurX | Experimental | Positioning of Pleurx drainage during surgical exploration if lung does not reinflate Receives: Device: PleurX |
| Pleurocath | Experimental | Positioning of Pleur o cath drainage during surgical exploration if lung does not reinflate Receives: Device: Pleurocath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)
Thoracic pain
Measured: Post operative day 4th
Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)
Dyspnea
Measured: Post operative day 4th
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start21 Apr 2017
- Primary completion3 Nov 2017
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleura; EffusionStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Petrella, MD, PhD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550027
- Sponsor's protocol ID
- R 574/17 - IEO 607
- Status last verified
- Jun 2018
- First submitted
- 21 Mar 2018
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indwelling Pleural Catheter for Trapped Lung: a Pilot Study for Power Calculation of a Randomized Controlled Trial Comparing Pleurocath® Versus PleurX®)
- ClinicalTrials.gov ID
- NCT03550027
- Acronym / sponsor ID
- R 574/17 - IEO 607
- Conditions
- Pleura; Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 8 Jun 2018 (actual)
- 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.
Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL).
The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PleurX | Experimental | Device: PleurXPositioning of Pleurx drainage during surgical exploration if lung does not reinflate |
| Pleurocath | Experimental | Device: PleurocathPositioning of Pleur o cath drainage during surgical exploration if lung does not reinflate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible)
Key exclusion criteria (10 listed)
- - Age younger than 18 years
- Expected survival of less than 3 months
- Chylothorax
- Total white blood cell count less than 1000/microL
- Pregnancy or lactating mothers
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 |
|---|---|---|
| PleurXPositioning of drainage PleurX | Device | PleurX |
| PleurocathPositioning of drainage Pleurocath | Device | Pleurocath |
Primary outcome
Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)
Time frame: Post operative day 4th
Thoracic pain
Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)
Time frame: Post operative day 4th
Dyspnea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Francesco Petrella, MD, PhD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PleurX and Pleurocath in people with Pleura; Effusion, run by European Institute of Oncology at 1 site in Italy.
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 10 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: finished, as of the sponsor's last update on 26 Nov 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain) (time frame: Post operative day 4th). 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 26 Nov 2024.