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LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009) (CROSSOVER)

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ClinicalTrials.gov Identifier: NCT02059057
Recruitment Status : Terminated (FDA approval of supplementation to IDE/protocol amendment to terminate subject long term follow up)
First Posted : February 11, 2014
Results First Posted : September 25, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Emphysema
Intervention Device: LVRC System
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LVRC System
Hide Arm/Group Description

The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Period Title: Overall Study
Started 102
Completed 87
Not Completed 15
Arm/Group Title LVRC System
Hide Arm/Group Description

The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
64.9  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
58
  56.9%
Male
44
  43.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Hispanic or Latino
1
   1.0%
Not Hispanic or Latino
101
  99.0%
Unknown or Not Reported
0
   0.0%
Six Minute Walk Test (6MWT)   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 102 participants
313.6  (82.0)
[1]
Measure Description: Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Forced Expiratory Volume in one second (FEV1)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 102 participants
0.7  (0.2)
[1]
Measure Description: The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.
Residual Volume (RV)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 102 participants
5.2  (1.3)
[1]
Measure Description: Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.
St. George's Respiratory Questionnaire (SGRQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units of a scale
Number Analyzed 102 participants
57.9  (15.6)
[1]
Measure Description:

The SGRQ is designed to measure health impairment in patients with asthma and COPD.

It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale)

Scores range from 0 to 100, with higher scores indicating more limitations.

A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.

1.Primary Outcome
Title Mean Change in Six Minute Walk Test (6MWT)
Hide Description Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time Frame Change in Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
Arm/Group Title LVRC System
Hide Arm/Group Description:

The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: meters
-22.9  (72.6)
2.Secondary Outcome
Title Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
Hide Description The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.
Time Frame Change in Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
Arm/Group Title LVRC System
Hide Arm/Group Description:
LVRC System
Overall Number of Participants Analyzed 83
Mean (Standard Deviation)
Unit of Measure: % change
2.2  (21.1)
3.Secondary Outcome
Title Mean Change in Residual Volume (RV)
Hide Description Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.
Time Frame Change in Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
Arm/Group Title LVRC System
Hide Arm/Group Description:

The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: Liters
-0.3  (0.7)
4.Secondary Outcome
Title Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
Hide Description

Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD.

It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale)

Scores range from 0 to 100, with higher scores indicating more limitations.

A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.

Time Frame Change in Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.
Arm/Group Title LVRC System
Hide Arm/Group Description:

The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Overall Number of Participants Analyzed 83
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.8  (14.8)
Time Frame 12 months
Adverse Event Reporting Description Crossover subjects who had been treated with at least one procedure or entered the procedure room comprise the safety population (n=101) and are included in the safety analyses for this clinical study report.
 
Arm/Group Title LVRC System
Hide Arm/Group Description

The Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.

RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

All-Cause Mortality
LVRC System
Affected / at Risk (%)
Total   9/101 (8.91%)    
Show Serious Adverse Events Hide Serious Adverse Events
LVRC System
Affected / at Risk (%) # Events
Total   56/101 (55.45%)    
Cardiac disorders   
Acute Myocardial Infarction  1  1/101 (0.99%)  1
Aortic Valve Stenosis  1  1/101 (0.99%)  1
Atrial flutter  1  1/101 (0.99%)  1
Cardiac Failure Congestive  1  1/101 (0.99%)  1
Cor Pulmonale  1  1/101 (0.99%)  1
Coronary Artery Disease  1  1/101 (0.99%)  1
Coronary Artery Occlusion  1  1/101 (0.99%)  1
Supraventricular Tachycardia  1  1/101 (0.99%)  1
Gastrointestinal disorders   
Diabetic Gastroparesis  1  1/101 (0.99%)  1
Gastritis  1  1/101 (0.99%)  1
Megacolon  1  1/101 (0.99%)  1
General disorders   
Medical Device Complication  1  3/101 (2.97%)  3
Non-Cardiac Chest Pain  1  2/101 (1.98%)  2
Hepatobiliary disorders   
Cholecystitis  1  1/101 (0.99%)  1
Infections and infestations   
Aspergillosis  1  1/101 (0.99%)  1
Gastroenteritis  1  1/101 (0.99%)  1
Infective Exacerbation of COPD  1  1/101 (0.99%)  2
Lower Respiratory Tract Infection  1  1/101 (0.99%)  1
Pneumonia  1  17/101 (16.83%)  20
Injury, poisoning and procedural complications   
Thoracic Vertebral Fracture  1  1/101 (0.99%)  2
Metabolism and nutrition disorders   
Back Pain  1  1/101 (0.99%)  1
Nervous system disorders   
Neuropathy Peripheral  1  1/101 (0.99%)  1
Renal and urinary disorders   
Renal Failure Acute  1  1/101 (0.99%)  1
Urinary Retention  1  1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Failure  1  1/101 (0.99%)  1
Chronic Obstructive Pulmonary Disease  1  23/101 (22.77%)  29
Dyspnoea  1  2/101 (1.98%)  2
Dyspnoea Exertional  1  1/101 (0.99%)  1
Haemoptysis  1  6/101 (5.94%)  6
Pleuritic Pain  1  1/101 (0.99%)  1
Pneumothorax  1  4/101 (3.96%)  5
Pulmonary Embolism  1  1/101 (0.99%)  1
Pulmonary Haemorrhage  1  2/101 (1.98%)  2
Respiratory Distress  1  1/101 (0.99%)  1
Respiratory Failure  1  1/101 (0.99%)  1
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LVRC System
Affected / at Risk (%) # Events
Total   97/101 (96.04%)    
General disorders   
Chest Discomfort  1  15/101 (14.85%)  21
Chest Pain  1  9/101 (8.91%)  9
Medical Device Complication  1  8/101 (7.92%)  8
Non-Cardiac Chest Pain  1  11/101 (10.89%)  14
Infections and infestations   
Pneumonia  1  20/101 (19.80%)  25
Musculoskeletal and connective tissue disorders   
Back Pain  1  6/101 (5.94%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Headache  1  9/101 (8.91%)  11
Respiratory, thoracic and mediastinal disorders   
Chronic Obstructive Pulmonary Disease  1  62/101 (61.39%)  110
Cough  1  16/101 (15.84%)  23
Dyspnoea  1  17/101 (16.83%)  21
Haemoptysis  1  58/101 (57.43%)  96
Oropharyngeal Pain  1  18/101 (17.82%)  26
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Danielle Barkema
Organization: PneumRx
Phone: 484-965-0060
EMail: Danielle.Barkema@btgplc.com
Layout table for additonal information
Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT02059057     History of Changes
Other Study ID Numbers: CLN0016
First Submitted: February 6, 2014
First Posted: February 11, 2014
Results First Submitted: July 16, 2018
Results First Posted: September 25, 2018
Last Update Posted: August 21, 2019