Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter (SWIFT)
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| ClinicalTrials.gov Identifier: NCT02649894 |
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Recruitment Status :
Completed
First Posted : January 8, 2016
Results First Posted : August 13, 2020
Last Update Posted : September 10, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Pleural Effusion | Device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter Device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 119 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | May 2016 |
| Actual Primary Completion Date : | April 18, 2018 |
| Actual Study Completion Date : | April 18, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
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Device: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)
Other Name: SNCIPC |
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Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter
Approved Uncoated PleurX Indwelling Pleural Catheter
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Device: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter |
- The Proportion of Subjects Achieving Pleurodesis Without Recurrence. [ Time Frame: 30 days post catheter insertion ]
- Time to Confirmed Pleurodesis [ Time Frame: 30 days post insertion ]
- Time to Recurrence [ Time Frame: 90 days post insertion ]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.
- Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days. [ Time Frame: Day 14, Day 30, Day 60, Day 90 ]
- Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others). [ Time Frame: 30 days. ]
- Incidence of IPC Occlusion [ Time Frame: 90 days ]
- Incidence of Empyema and Cellulitis [ Time Frame: 90 days ]
- Pain Using 100 mm Visual Analog Scale (VAS) [ Time Frame: Baseline,Day 7, 14, 30, 45, 75, and 90 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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:
- There is histocytological confirmation of pleural malignancy
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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:
- A CXR shows hydropneumothorax.
- 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.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649894
Show 19 study locations
| Principal Investigator: | Joseph B Shrager, MD | Stanford University |
Documents provided by CareFusion:
| Responsible Party: | CareFusion |
| ClinicalTrials.gov Identifier: | NCT02649894 |
| Other Study ID Numbers: |
CS-IP-VH-14-009 |
| First Posted: | January 8, 2016 Key Record Dates |
| Results First Posted: | August 13, 2020 |
| Last Update Posted: | September 10, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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malignant pleural effusion |
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Pleural Effusion, Malignant Pleural Effusion Pleural Diseases Respiratory Tract Diseases Pleural Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Silver Nitrate Anti-Infective Agents, Local Anti-Infective Agents |