Malignant Pleural EffusionNCT03403855
Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients
A study testing Rocket® IPC- Long External Length and Rocket® IPC- Short External Length in people with Malignant Pleural Effusion, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- Rocket® IPC- Long External Length and Rocket® IPC- Short External Length
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2018to 31 Dec 2021
- 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
- Presence of symptomatic (BDI < 6), and moderate sized (> 1/3 of hemithorax) MPE
- Persistent malignant pleural effusion that is free flowing
- Life expectancy of at least 2 months (approximate duration of follow-up for the study)
- Age greater than 18
- Consent to undergoing TPC treatment for recurrent MPE
Who cannot join
- Prior attempted chemical pleurodesis on ipsilateral side
- Active pleural or pulmonary infection
- Currently hospitalized for reasons other than MPE or in hospice care
- Life expectancy estimated at less than 2 months
- Inability to complete questionnaires (English or French)
- Refusal to give informed consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ottawa Hospital, General Campus
Ottawa, Ontario, K1H 8L6
Rosalie Labelle, MSc, 613-737-8899 ext. 75256, rolabelle@toh.ca
Kayvan Amjadi, MD
About this study
Official title: Evaluation of Short and Long External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction.
Read the detailed description
Pleural effusion is a medical condition, which occurs when too much fluid collects in the space between the lungs and the chest wall. This extra fluid makes it hard for the lungs to fully expand and take in enough air when inhaling. Malignant pleural effusions (MPE) are effusions related to cancer. Common symptoms of MPE include: dyspnea (shortness of breath), cough, weight loss, and chest pain. Tunneled pleural catheters (which are inserted into the body) are now commonly used to treat the symptoms of malignant pleural effusions by draining this extra fluid on a daily basis. This drainage can be done and home and need not be performed at a hospital.
The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction. The Rocket® pleural catheter has been approved by the Food and Drug Administration (FDA) and Health Canada for the management of malignant pleural effusions.
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. All information required to evaluate the Rocket® catheter will be collected from routine medical follow-up visits. The period of time for the study is approximately 4 weeks (28 days).
The Rocket® catheter will be provided to patients who wish to participate in this study. If patients do not wish to participate, they will receive the current standard of care (the PleurX catheter) and will undergo the same standard medical assessments that will be performed in this study.
All patients eligible for the study will have a regular full length Rocket catheter inserted at baseline, with an external length of 16cm. All patients will have their catheter length modified at 2 weeks in clinic and shortened to an external length of 5cm.
- Conditions
- Malignant Pleural Effusion
- Being tested
- Rocket® IPC- Long External Length, Rocket® IPC- Short External Length
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocket® IPC- Long External LengthDevice
Rocket® IPC- Long External Length Intervention. Evaluation of Long and Short External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions
Rocket® IPC- Short External LengthDevice
Rocket® IPC- Short External Length Intervention. Evaluation of Long and Short External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions
| Study group | Role | What they receive |
|---|---|---|
| Rocket® IPC- Long External Length | Experimental | Intervention Rocket® IPC- Long External Length: a regular full length (long catheter) Rocket catheter inserted at baseline, with an external length of 16cm. Catheter length will be modified at 2 weeks in clinic, shortened to an external length of 5cm (short catheter). Patient satisfaction will be collected at 2 weeks prior to the modification, and at 4 weeks when the patient has a shorter catheter.
The modification is easily done without any use of anesthesia as it is external to the patient using the tool kit that comes along with the catheter.
Patients will be referred to palliative home care services for assistance with drainage. The drainage catheters to be used in this study will be samples supplied by Rocket Medical Inc., for Dr. Amjadi to evaluate their product. Receives: Device: Rocket® IPC- Long External Length |
| Rocket® IPC- Short External Length | Experimental | Intervention Rocket® IPC- Short External Length : a regular full length (long catheter) Rocket catheter inserted at baseline, with an external length of 16cm. Catheter length will be modified at 2 weeks in clinic, shortened to an external length of 5cm (short catheter). Patient satisfaction will be collected at 2 weeks prior to the modification, and at 4 weeks when the patient has a shorter catheter.
The modification is easily done without any use of anesthesia as it is external to the patient using the tool kit that comes along with the catheter.
Patients will be referred to palliative home care services for assistance with drainage. The drainage catheters to be used in this study will be samples supplied by Rocket Medical Inc., for Dr. Amjadi to evaluate Rocket's product. Receives: Device: Rocket® IPC- Short External Length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion.
Self-rated QOL at baseline compared to 2 weeks and 4 weeks post catheter insertion.
Quality of life will be assessed using the validated EORTC QLQ-C30 (European Organization of Research and Treatment of Cancer Quality of Life Evaluation) questionnaire.
Measured: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.
Patients' self-rated quality of life on domains specific to lung cancer-change from baseline compared to 2 and 4 weeks post catheter insertion.
Self-rated QOL in domains specific to lung cancer will be assessed at baseline compared to 2 weeks and 4 weeks post catheter insertion.
Quality of life will be assessed using the validated lung cancer specific EORTC QLQ-LC13 (European Organization of Research and Treatment of Cancer (EORTC) Quality of Life QLQ-LC13 disease specific) questionnaire.
Measured: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.
Secondary outcomes (2)
Ease of use of the short versus long Rocket® pleural catheter.
Ease of use of the short versus long Rocket pleural catheter as reported by the study doctor as well as the hospital and home care nursing staff.
Ease of use will be measured using a non-validated questionnaire, which will assess the functionality of the short versus long Rocket® pleural catheter.
Measured: Questionnaire will be administered at routine medical visits on day O, 14, and 28.
Feasibility: measured by incidence of complications (adverse events reports)
Feasibility will be measured by the incidence of complications found in patients using short versus long Rocket® pleural catheters to treat symptoms of MPE as well as hospital and home care nursing staffs' level of satisfaction with the Rocket® catheter.
The time to removal of the Rocket catheter will also be followed and complications will be quantified and described based on patients' reporting of adverse events (at 2 week and 4 week medical assessments) and ongoing reports from home care nurses. All complications will be documented, the most clinically relevant include pleural infection and cellulitis, pain, and catheter obstruction and symptomatic loculated effusion.
Measured: Complications will be quantified and described based on patients' reporting of adverse events (at 2 week and 4 week medical assessments). Satisfaction with device questionnaires will be administered at routine medical visits on day 0, 14 and 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start7 Mar 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All patients will have a regular full length Rocket catheter inserted at baseline, with an external length of 16cm. All patients will have their catheter length modified at 2 weeks in clinic and shortened to an external length of 5cm. Patient satisfaction will be collected at 2 weeks prior to the modification, and 4 weeks when the patient has a shorter catheter. The modification is easily done without any use of anesthesia as it is external to the patient. It is done with the tool kit that comes along with the catheter. All patients will be referred to palliative home care services for assistance with drainage. Drainage catheters are usually provided by Ontario Medical Supplies. However, the drainage catheters to be used in this study will be those supplied by Rocket Medical Inc., as they will be providing Dr. Amjadi with some samples to evaluate their product.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kayvan Amjadi, MD, Principal investigator, Director Interventional Pulmonology, TOH (General Campus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403855
- Sponsor's protocol ID
- 20170753-01H
- Status last verified
- Sep 2020
- First submitted
- 31 Oct 2017
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short and Long External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT03403855
- Acronym / sponsor ID
- 20170753-01H
- Conditions
- Malignant Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Jan 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.
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction.
Detailed description
Pleural effusion is a medical condition, which occurs when too much fluid collects in the space between the lungs and the chest wall. This extra fluid makes it hard for the lungs to fully expand and take in enough air when inhaling. Malignant pleural effusions (MPE) are effusions related to cancer. Common symptoms of MPE include: dyspnea (shortness of breath), cough, weight loss, and chest pain. Tunneled pleural catheters (which are inserted into the body) are now commonly used to treat the symptoms of malignant pleural effusions by draining this extra fluid on a daily basis. This drainage can be done and home and need not be performed at a hospital.
The aim of this study is to evaluate the effectiveness of the shorter versus longer external length Rocket® pleural catheter in managing malignant pleural effusions in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction. The Rocket® pleural catheter has been approved by the Food and Drug Administration (FDA) and Health Canada for the management of malignant pleural effusions.
This study will take place in Ottawa, Ontario, and will include 100 patients who are receiving tunnelled pleural catheters to treat their symptoms of MPE. All information required to evaluate the Rocket® catheter will be collected from routine medical follow-up visits. The period of time for the study is approximately 4 weeks (28 days).
The Rocket® catheter will be provided to patients who wish to participate in this study. If patients do not wish to participate, they will receive the current standard of care (the PleurX catheter) and will undergo the same standard medical assessments that will be performed in this study.
All patients eligible for the study will have a regular full length Rocket catheter inserted at baseline, with an external length of 16cm. All patients will have their catheter length modified at 2 weeks in clinic and shortened to an external length of 5cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will have a regular full length Rocket catheter inserted at baseline, with an external length of 16cm. All patients will have their catheter length modified at 2 weeks in clinic and shortened to an external length of 5cm. Patient satisfaction will be collected at 2 weeks prior to the modification, and 4 weeks when the patient has a shorter catheter. The modification is easily done without any use of anesthesia as it is external to the patient. It is done with the tool kit that comes along with the catheter. All patients will be referred to palliative home care services for assistance with drainage. Drainage catheters are usually provided by Ontario Medical Supplies. However, the drainage catheters to be used in this study will be those supplied by Rocket Medical Inc., as they will be providing Dr. Amjadi with some samples to evaluate their product.
| Arm | Type | Receives |
|---|---|---|
| Rocket® IPC- Long External Length | Experimental | Device: Rocket® IPC- Long External LengthIntervention Rocket® IPC- Long External Length: a regular full length (long catheter) Rocket catheter inserted at baseline, with an external length of 16cm. Catheter length will be modified at 2 weeks in clinic, shortened to an external length of 5cm (short catheter). Patient satisfaction will be collected at 2 weeks prior to the modification, and at 4 weeks when the patient has a shorter catheter. The modification is easily done without any use of anesthesia as it is external to the patient using the tool kit that comes along with the catheter. Patients will be referred to palliative home care services for assistance with drainage. The drainage catheters to be used in this study will be samples supplied by Rocket Medical Inc., for Dr. Amjadi to evaluate their product. |
| Rocket® IPC- Short External Length | Experimental | Device: Rocket® IPC- Short External LengthIntervention Rocket® IPC- Short External Length : a regular full length (long catheter) Rocket catheter inserted at baseline, with an external length of 16cm. Catheter length will be modified at 2 weeks in clinic, shortened to an external length of 5cm (short catheter). Patient satisfaction will be collected at 2 weeks prior to the modification, and at 4 weeks when the patient has a shorter catheter. The modification is easily done without any use of anesthesia as it is external to the patient using the tool kit that comes along with the catheter. Patients will be referred to palliative home care services for assistance with drainage. The drainage catheters to be used in this study will be samples supplied by Rocket Medical Inc., for Dr. Amjadi to evaluate Rocket's product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of symptomatic (BDI < 6), and moderate sized (> 1/3 of hemithorax) MPE
- Persistent malignant pleural effusion that is free flowing
- Life expectancy of at least 2 months (approximate duration of follow-up for the study)
- Age greater than 18
- Consent to undergoing TPC treatment for recurrent MPE
Key exclusion criteria (7 listed)
- Prior attempted chemical pleurodesis on ipsilateral side
- Active pleural or pulmonary infection
- Currently hospitalized for reasons other than MPE or in hospice care
- Life expectancy estimated at less than 2 months
- Inability to complete questionnaires (English or French)
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 |
|---|---|---|
| Rocket® IPC- Long External LengthRocket® IPC- Long External Length Intervention. Evaluation of Long and Short External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions | Device | Rocket® IPC- Long External Length |
| Rocket® IPC- Short External LengthRocket® IPC- Short External Length Intervention. Evaluation of Long and Short External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions | Device | Rocket® IPC- Short External Length |
Primary outcome
Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion.
Time frame: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.
Self-rated QOL at baseline compared to 2 weeks and 4 weeks post catheter insertion. Quality of life will be assessed using the validated EORTC QLQ-C30 (European Organization of Research and Treatment of Cancer Quality of Life Evaluation) questionnaire.
Patients' self-rated quality of life on domains specific to lung cancer-change from baseline compared to 2 and 4 weeks post catheter insertion.
Time frame: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.
Self-rated QOL in domains specific to lung cancer will be assessed at baseline compared to 2 weeks and 4 weeks post catheter insertion. Quality of life will be assessed using the validated lung cancer specific EORTC QLQ-LC13 (European Organization of Research and Treatment of Cancer (EORTC) Quality of Life QLQ-LC13 disease specific) questionnaire.
2 secondary outcomes
Ease of use of the short versus long Rocket® pleural catheter.
Time frame: Questionnaire will be administered at routine medical visits on day O, 14, and 28.
Feasibility: measured by incidence of complications (adverse events reports)
Time frame: Complications will be quantified and described based on patients' reporting of adverse events (at 2 week and 4 week medical assessments). Satisfaction with device questionnaires will be administered at routine medical visits on day 0, 14 and 28.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
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UNC Pleural Fluid Registry
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Intrapleural Catheter Daily Versus Three Times a Week Drainage
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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.
Kayvan Amjadi, MD principal investigator
Director Interventional Pulmonology, TOH (General Campus)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocket® IPC- Long External Length and Rocket® IPC- Short External Length in people with Malignant Pleural Effusion, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 5 inclusion and 7 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 25 Sep 2020. 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 Canada. 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?
Contact Rosalie Labelle, MSc (613-737-8899 ext. 75256, rolabelle@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' self-rated quality of life - change from baseline compared to 2 and 4 weeks post catheter insertion. (time frame: Assessed at baseline compared to changes at 2 weeks and 4 weeks post catheter insertion. Questionnaires will be administered at routine medical visits on day O, 14, and 28.). 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 25 Sep 2020.