Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter

Malignant Pleural Effusion Clinical Trial

— SWIFT  

Official title:

Pivotal Multi Center, Randomized, Controlled, Single-Blinded Study Comparing the Silver Nitrate Coated Indwelling Pleural Catheter to the Uncoated PleurX Catheter for the Management of Symptomatic, Recurrent, Malignant Pleural Effusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649894
• Other study ID #: CS-IP-VH-14-009
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 18, 2018

Study information

• Verified date: August 2020
• Source: CareFusion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions compared to approve catheter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Device:
• Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

• Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Locations

Country	Name	City	State
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Oxford Center for Respiratory Medicine, Churchill Hospital	Oxford
United Kingdom	Great Western Hospital	Swindon
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Beth Israel Deconess Medical Center West	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	UNC Hospital	Chapel Hill	North Carolina
United States	Northwestern Unversity	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	University of Texas, MD Anderson Cancer Center	Houston	Texas
United States	Heart Center Research	Huntsville	Alabama
United States	St. Vincent Medical Group	Indianapolis	Indiana
United States	Vanderbuilt University	Nashville	Tennessee
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Washington Universtiy School of Medicine, Barnes Jewish Hospital	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Stanford University School of Medicine/ Stanford Cancer Institute	Stanford	California
United States	SUNY Upstate Hospital	Syracuse	New York
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CareFusion

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.		Day 14, Day 30, Day 60, Day 90
Other	Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others).		30 days.
Other	Incidence of IPC Occlusion		90 days
Other	Incidence of Empyema and Cellulitis		90 days
Other	Pain Using 100 mm Visual Analog Scale (VAS)	Chest pain was measured using a 100 mm VAS scale at baseline and at each subsequent visit. The resulting VAS score ranges from 0 to 100, with 0 indicating "No pain" and 100 indicating "Very severe pain". Therefore, the lower the number, the less chest pain the subject is feeling at the time.	Baseline,Day 7, 14, 30, 45, 75, and 90
Primary	The Proportion of Subjects Achieving Pleurodesis Without Recurrence.		30 days post catheter insertion
Secondary	Time to Confirmed Pleurodesis		30 days post insertion
Secondary	Time to Recurrence	This endpoint was meant to measure time to recurrence; however, only 1 participant (in the SNCIPC group) had a recurrence so this outcome could not be analyzed.	90 days post insertion