Status:

UNKNOWN

Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients

Lead Sponsor:

Ottawa Hospital Research Institute

Conditions:

Malignant Pleural Effusion

Eligibility:

All Genders

18+ years

Phase:

NA

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 effe...

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 t...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

March 7 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2021

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT03403855

Start Date

March 7 2018

End Date

December 31 2021

Last Update

September 25 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Ottawa Hospital, General Campus

Ottawa, Ontario, Canada, K1H 8L6