ClinicalTrials.gg
CompletedNCT03414905Updated Feb 20, 2024

Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System

An observational study in Malignant Pleural Effusion, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 52 studies in Pleural Effusion, Malignant with a site in United States — 6 open to participants now, 8 under way, none of them phase 3. Pleural Effusion, Malignant · United States.

Started
2018
with 1 other
Observational
8 of 52
3 open now
Registered
41st of 52
by date

Among the 52 studies in Pleural Effusion, Malignant with a site in United States, this one is one of 2 that started in 2018, is one of 8 observational ones, and was the 41st registered.

Pleural Effusion, Malignant

169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.

Browse Pleural Effusion, Malignant studies →

Open to participants now

6 of the 52 studies in Pleural Effusion, Malignant with a site in United States are open now. Recruiting first, the newest first:

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All 6 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 25 Pleural Effusion, Malignant studies recruiting now, 15 (60%) set no upper age limit and 5 (20%) stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

In this study, the investigators will collect data on patients who are using the Aspira system as part of their clinical care for the management of recurrent pleural effusion. Data will be collected on patient demographics, placement of the pleural catheter, palliation of dyspnea, complication rates, and rates of spontaneous pleurodesis.

03

Conditions studied

  • Malignant Pleural Effusion
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The participants will be seen at Washington University School of Medicine.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female, at least 18 years of age, inclusive
  • Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true

    • There is cytological confirmation of pleural
    • The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein >0.5, Pleural fluid LDH/Serum LDH >0.6, or Pleural fluid LDH >2/3 the ) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
  • Subject is able to provide
  • Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
  • Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).

Exclusion criteria

Exclusion Criteria:

  • Subject is pregnant
  • Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
  • Subjects with uncorrected coagulopathy
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Aspira Catheter & Drainage System

    * Participants will have standard of care ultrasound and placement of the Aspira Catheter and Drainage System on Day 1 * The removal of the Aspira Catheter and Drainage System will be dependent upon future ultrasound assessment and fluid output

    Device: Aspira Catheter · Procedure: Ultrasound

Interventions

  • DeviceAspira Catheter

    * 15.5Fr catheter * Standard of care

    Also known as: Aspira Catheter and Drainage System

  • ProcedureUltrasound

    Standard of care

06

What researchers measure

Primary outcomes

  1. Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea)

    * This will be determined based on the difference between the VAS-Dyspnea score on the day of catheter insertion prior to catheter insertion compared with the VAS-Dyspnea score on the 2 week follow up visit * The scale presents the question "how much shortness of breath are you having right now?" with a straight line. At one end it states "no shortness of breath" and the other end is "shortness of breath as bad as can be". The participant will mark the line on how they feel * No shortness is breath is 0% score and shortness of breath as bad as can be is 100% score

    Time frame: Through 2 weeks following catheter insertion

Secondary outcomes

  1. Rate of infection

    -Defined as the isolation of any bacteria within a pleural fluid specimen drawn for clinical purposes

    Time frame: 1 year

  2. Rate of spontaneous pleurodesis

    -Defined as pleural fluid drainage less than 75ml every other day for three consecutive drainage sessions

    Time frame: 1 year

07

Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Sep 2023, 62 months.

Of 22 observational studies under Pleural Effusion, Malignant, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's 62 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Jan 30, 2018
StartActual
Jul 9, 2018
Primary completionActual
Sep 26, 2023
CompletionActual
Feb 15, 2024
Last update
Feb 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03414905
Responsible party
Sponsor
First posted
Jan 30, 2018
Start date
Jul 9, 2018
Primary completion
Sep 26, 2023
Completion
Feb 15, 2024
Last update
Feb 20, 2024

Study contacts

Alexander Chen, M.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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