Pleural Irrigation With a Novel Devise.

NCT ID: NCT06727578

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-25

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pleural Effusion Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

of intrapleural saline irrigation with CLR irrigator

Intervention Type 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.

Interventions

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of intrapleural saline irrigation with CLR irrigator

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Adnan Majid, MD

Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School,

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Conley

Role: CONTACT

617-632-8386

References

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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.

Reference Type BACKGROUND
PMID: 20696693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33001756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24394842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21617169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7424940 (View on PubMed)

Other Identifiers

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2024P000822

Identifier Type: -

Identifier Source: org_study_id

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