Recruiting

Rocket® Pleural Catheters

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03403855

Conditions

Malignant Pleural Effusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rocket® IPC- Long External Length

Rocket® IPC- Short External Length

Study Details

Brief 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 in terms of patients' self-rated quality of life, its ease of use, the incidence of complications, and levels of health care provider satisfaction.

Conditions

Malignant Pleural Effusion

Study ID

NCT03403855

Start date

Mar 7, 2018

Status verified date

Sep, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Presence of symptomatic (BDI < 6), and moderate sized (> 1/3 of hemithorax) MPE
2. Persistent malignant pleural effusion that is free flowing
3. Life expectancy of at least 2 months (approximate duration of follow-up for the study)
4. Age greater than 18
5. Consent to undergoing TPC treatment for recurrent MPE

Exclusion Criteria:

1. Prior attempted chemical pleurodesis on ipsilateral side
2. Active pleural or pulmonary infection
3. Currently hospitalized for reasons other than MPE or in hospice care
4. Life expectancy estimated at less than 2 months
5. Inability to complete questionnaires (English or French)
6. Refusal to give informed consent
7. Pregnant women

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rocket® IPC- Long External Length

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.

experimental: Rocket® IPC- Short External Length

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.

Interventions

Rocket® IPC- Long External Length

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 Length

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

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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Rosalie Labelle, MSc

613-737-8899rolabelle@toh.ca

Locations

Ottawa Hospital, General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Rosalie Labelle, MSc

613-737-8899rolabelle@toh.ca

Principal Investigator:

Kayvan Amjadi, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Sep 25, 2020

Last verified

Sep, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2020-09-25.