Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02649894
Other study ID # CS-IP-VH-14-009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT00052338 - Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06421610 - OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion. Phase 1
Recruiting NCT04793607 - Interventions for Malignant Pleural Effusions Impact on Fatigue
Recruiting NCT03987087 - A Randomized Study of Primary Tumor Radiotherapy for Patients With MPE Stage IV NSCLC Phase 2
Recruiting NCT02942043 - Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer Phase 2
Completed NCT01997190 - Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion Phase 1
Completed NCT00564733 - FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Phase 2
Not yet recruiting NCT04131231 - Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion N/A
Completed NCT02674243 - Efficacy of Iodopovidone Versus Talc in Palliative Malignant Pleural Effusion Phase 3
Terminated NCT01004510 - Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer Phase 2
Completed NCT00528645 - AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer Phase 2
Recruiting NCT00313066 - Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion Phase 4
Terminated NCT04236037 - Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura N/A
Completed NCT05372055 - Malignant Pleural Effusions: Evaluating the psYchosocial Impact of Indwelling Pleural Catheters on Patients
Not yet recruiting NCT04914598 - A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions Phase 3
Recruiting NCT04322136 - AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion N/A
Recruiting NCT03973957 - Talc Outpatient Pleurodesis With Indwelling Catheter N/A
Recruiting NCT05923515 - A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion Phase 1
Recruiting NCT03403855 - Rocket® Pleural Catheters: QOL, Feasibility and Satisfaction in Recurrent MPE Patients N/A
Terminated NCT03597009 - A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion Phase 1/Phase 2