Clinical trial · Observational
Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System
NCT03414905CI-TRIAL-00074121completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspira Catheter | Device | — | UNRESOLVED |
| Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Aspira Catheter & Drainage System
- description
- * 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
- interventionNames
- Device: Aspira Catheter
- Procedure: Ultrasound
Primary outcomes (1)
- measure
- Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea)
- timeFrame
- Through 2 weeks following catheter insertion
- description
- * 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
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 malignancy * 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 upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified * Subject is able to provide informed consent * 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: * Subject is pregnant * Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection * Subjects with uncorrected coagulopathy
References
Publications (0)
Data not yet available
No reference posted for this study.