Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasms

Recurrence

Pleural Effusion

Pleural Effusion, Malignant

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Silver Nitrate

Anti-Infective Agents, Local

Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Approved Uncoated PleurX Indwelling Pleural Catheter

Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Joseph B Shrager, MD

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.

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

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

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.

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.

CareFusion

Participants were monitored for Adverse Events at each study visit (15, 30, 45, 60, 75, 90 days)

Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)

Approved Uncoated PleurX Indwelling Pleural Catheter

Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter

Total

Age, Continuous

Gender

Sex/Gender, Customized

Race (NIH/OMB)

United States

United Kingdom

Region of Enrollment

Large number of deviations (e.g. missed procedures) affected interpretability of data \& device performance. Independent adjudication of complex endpoints may have facilitated interpretation, had it been included in the study.

Dawn Heimer

All participants who successfully had the catheter placed.

The Proportion of Subjects Achieving Pleurodesis Without Recurrence.

Participants who had catheter successfully inserted

Time to Confirmed Pleurodesis

Time to Recurrence

Day 14

Day 30

Day 60

Day 90

Participants with catheter successfully placed

Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days.

Lung Cancer

Breast Cancer

Other Cancer

Participants with successfully placed catheter

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter	NCT02649894	Malignant Pleur...	Active Comparat... Experimental: S...	18 Years -	CareFusion
Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter	NCT02649894	Malignant Pleur...	Active Comparat... Experimental: S...	18 Years -	CareFusion

Spots Global Cancer Trial Database for active comparator: approved uncoated pleurx indwelling pleural catheter