Pleural Irrigation With a Novel Devise.

NCT06727578 | Recruiting FDA Device

• 1 other identifier: 2024P000822
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pleural Effusion Disorder

Outcome Measures

Primary Outcomes (1)

• Radiographic improvement (reduction in the ammount of pleural effusion messured in centimeters) by bed side ultrasound day 1,2,3,4,5.

  Daily for 8 days

Study Arms (1)

Treatment

EXPERIMENTAL

Device: of intrapleural saline irrigation with CLR irrigator

Interventions

of intrapleural saline irrigation with CLR irrigator 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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify if:

• Non-infectious cause of pleural fluid analysis findings listed above identified (e.g. malignancy)
• Post-procedural empyema or complicated parapneumonic effusion

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (5)

• Davies HE, Davies RJ, Davies CW; BTS Pleural Disease Guideline Group. Management of pleural infection in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii41-53. doi: 10.1136/thx.2010.137000. No abstract available.

  PMID: 20696693 BACKGROUND

• Gupta I, Eid SM, Gillaspie EA, Broderick S, Shafiq M. Epidemiologic Trends in Pleural Infection. A Nationwide Analysis. Ann Am Thorac Soc. 2021 Mar;18(3):452-459. doi: 10.1513/AnnalsATS.202001-075OC.

  PMID: 33001756 BACKGROUND

• Sogaard M, Nielsen RB, Norgaard M, Kornum JB, Schonheyder HC, Thomsen RW. Incidence, length of stay, and prognosis of hospitalized patients with pleural empyema: a 15-year Danish nationwide cohort study. Chest. 2014 Jan;145(1):189-192. doi: 10.1378/chest.13-1912. No abstract available.

  PMID: 24394842 BACKGROUND

• Grijalva CG, Zhu Y, Nuorti JP, Griffin MR. Emergence of parapneumonic empyema in the USA. Thorax. 2011 Aug;66(8):663-8. doi: 10.1136/thx.2010.156406. Epub 2011 May 26.

  PMID: 21617169 BACKGROUND

• Light RW, Girard WM, Jenkinson SG, George RB. Parapneumonic effusions. Am J Med. 1980 Oct;69(4):507-12. doi: 10.1016/0002-9343(80)90460-x.

  PMID: 7424940 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Central Study Contacts

Christine Conley

CONTACT

617-632-8386; Cconley@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School,

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: December 11, 2024
• Study Start: May 25, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)