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Silver-coated chest tube shows promise for cancer fluid relief

NCT ID NCT02649894

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new type of chest tube coated with silver nitrate against a standard tube for people with recurrent fluid buildup in the chest due to cancer. The goal was to see if the coated tube could seal the space and prevent fluid from coming back more effectively. 119 adults with symptomatic malignant pleural effusion took part. The main measure was how many people achieved pleurodesis (lung sealing) without recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
silver nitrate-coated indwelling pleural catheter
What this could lead to
If it works, this could offer a more effective way to control fluid buildup in the chest for people with cancer, reducing the need for repeat procedures.
What could go wrong
This is a small, completed study (119 people) comparing a coated catheter to an approved one. The coating may not provide significant benefit, and there is a risk of infection or other complications from the device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

119 people

The number who actually took part.

Start date

May 2016

Finished

Apr 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Male or female, at least 18 years of age, inclusive. 2. Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true: 1. There is histocytological confirmation of pleural malignancy 2. The effusion is an exudate (per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified. 3\. Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved. 4\. Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls. 6\. Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7. Subject has negative pregnancy test if appropriate. 8. Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member or paid healthcare professional and applies to US sites only; UK subjects will have drainage managed by home-care nurses). Exclusion Criteria: * 1\. Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, 2 separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after a pleural drainage. Significant trapped lung is deemed present if any 1 of the following criteria is met: 1. A CXR shows hydropneumothorax. 2. A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid. 3. A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough). 2\. Subject has a Karnofsky score \<50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more. 3\. Subject is pregnant, planning to become pregnant, or is lactating. 4. Subject has a history of empyema. 5. Subject has a history of chylothorax. 6. Subject has an uncorrected coagulopathy. 7. Subject has a hypersensitivity to new or existing pleural catheter or it's components. 8\. Subject has evidence, in the opinion of the Investigator, of either on-going systemic or pleural infection. 9\. Subject has had a lobectomy or pneumonectomy on the side of the effusion. 10. Subject has undergone a previous attempt at ipsilateral pleurodesis which has failed. 11\. Subject has previously been diagnosed with a serious immunodeficiency disorder. 12\. Subject has bilateral pleural effusions, with both being at least moderate in size (greater than one-third of the hemithorax on CXR). 13\. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile. 14\. Subject has a mediastinal shift of ≥2 cm toward the side of the effusion. 15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest. 16\. Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would mean participation in the study would be contraindicated. 17\. Subject has no access to a telephone. 18. Subject has no documented blood values (complete blood count \[CBC\], coagulation tests, urea and electrolytes, and liver function tests \[LFTs\]) within the last 10 days. 19\. Subject has previously participated in any clinical trial with the investigational device. 20\. Subject currently enrolled in any other clinical investigation or who has participated in any clinical investigation in the 30 days prior to starting this study.

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Conditions

The condition(s) this trial relates to.

Pleural Effusion, Malignant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beth Israel Deconess Medical Center West

    Boston, Massachusetts, 02215, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Great Western Hospital

    Swindon, United Kingdom

  • Heart Center Research

    Huntsville, Alabama, 35801, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Northwestern Unversity

    Chicago, Illinois, 60611, United States

  • Oxford Center for Respiratory Medicine, Churchill Hospital

    Oxford, United Kingdom

  • SUNY Upstate Hospital

    Syracuse, New York, 13210, United States

  • Southmead Hospital

    Bristol, United Kingdom

  • St. Vincent Medical Group

    Indianapolis, Indiana, 46260, United States

  • Stanford University School of Medicine/ Stanford Cancer Institute

    Stanford, California, 94305, United States

  • UNC Hospital

    Chapel Hill, North Carolina, 27599, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Vanderbuilt University

    Nashville, Tennessee, 37232, United States

  • Washington Universtiy School of Medicine, Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

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