Pleural Effusion DisorderLungs and breathingDevice
What this study is
Single-arm pilot trial of the use of intrapleural saline irrigation to treat retained pleural infections for patients with contraindications to standard of care intrapleural enzymatic therapy.
What's being tested
- of intrapleural saline irrigation with CLR irrigator
Intervention · DEVICE
patients will have a CLRTM port and CLRTM irrigator (CLR Medical, Calverton, MD, USA) added to their chest tube and atrium circuit to facilitate pleural irrigation.
Study details
- Official title
- A Pilot Assessment of the Safety and Efficacy of Pleural Irrigation for Retained Pleural Infection Using a Novel Irrigation Device
- Sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Pleural Effusion Disorder
- Enrolling
- 10 people
- Starts
- 2025-05-25
- Est. completion
- 2027-07-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Retained pleural effusion identified via bedside ultrasound within the first 24 hours after chest tube insertion
- Patient is contraindicated from receiving intrapleural enzymatic therapy within the first 24 hours after chest tube insertion
You can't join if
- Non-infectious cause of pleural fluid analysis findings listed above identified (e.g. malignancy)
- Post-procedural empyema or complicated parapneumonic effusion
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Recruiting
Study team
Sponsor
Beth Israel Deaconess Medical Center
Study ID 2024P000822
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.