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The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.
The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.
The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.
It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.
Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve System was approved by the FDA for the treatment of severe emphysema in June 2018. Following this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5 years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under the auspices of the "LIBERATE Extension Study". This is an administrative change with absolutely no change to the design or conduct of the study and, therefore has no material impact to the study participants or the study sites. All annual follow-up visits and evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the LIBERATE Extension Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBV and Optimal Medical Management | Experimental | This study arm will undergo EBV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
|
| Optimal Medical Management | Other | This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBV | Device | This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1-second (FEV1) | The percentage of study participants in the Zephyr Valve EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of >15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Post-bronchodilator Absolute Change | Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline). | 1 year |
| St. George's Respiratory Questionnaire (SGRQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Criner, MD | Temple University Hospital, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Arizona Pulmonary Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39515624 | Derived | Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6. | |
| 32223724 | Derived | Dransfield MT, Garner JL, Bhatt SP, Slebos DJ, Klooster K, Sciurba FC, Shah PL, Marchetti NT, Sue RD, Wright S, Rivas-Perez H, Wiese TA, Wahidi MM, Goulart de Oliveira H, Armstrong B, Radhakrishnan S, Shargill NS, Criner GJ; LIBERATE Study Group:. Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial. Ann Am Thorac Soc. 2020 Jul;17(7):829-838. doi: 10.1513/AnnalsATS.201909-666OC. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EBV and Optimal Medical Management | This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. EBV: This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 23, 2017 | Sep 6, 2018 |
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| Optimal Medical Management | Other | This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
|
Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline).
The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:
Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)
A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.
| 1 year |
| 6-minute Walk Distance | Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline). | 1 year |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| El Camino Hospital | Mountain View | California | 94040 | United States |
| University of California at Davis Medical Center | Sacramento | California | 95817 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Stanford University | Stanford | California | 94507 | United States |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| University of Louisville Research Foundation | Louisville | Kentucky | 40202 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Hospital de Clinicas Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| INCOR - Hospital das Clinicas de Faculdade de Medicine da USP | São Paulo | São Paulo | 05403-000 | Brazil |
| University Medical Center Groningen | Groningen | 9700 | Netherlands |
| Bristol Royal Infirmary | Bristol | BS2 8HW | United Kingdom |
| University Hospital Llandough and University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Royal Brompton & Harefield NHS Foundation Trust | London | SW3 6NP | United Kingdom |
| 29787288 | Derived | Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC. |
| FG001 | Optimal Medical Management | This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zephyr Valve Treatment and Optimal Medical Management | This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
| BG001 | Optimal Medical Management | This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | inches |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
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| Pack Years Smoking History | Calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. | Mean | Standard Deviation | pack-years |
| ||||||||||||||
| FEV1 Post-Bronchodilator (liters) | Mean | Standard Deviation | liters |
| |||||||||||||||
| FEV1 Post-Bronchodilator (% predicted) | Mean | Standard Deviation | %predicted |
| |||||||||||||||
| FVC (liters) | Mean | Standard Deviation | liters |
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| FVC (% predicted) | Mean | Standard Deviation | %predicted |
| |||||||||||||||
| Diffusing Capacity (mL CO/min/mm Hg) | Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data. | Mean | Standard Deviation | mL CO / min / mmHg |
| ||||||||||||||
| Diffusing Capacity (% predicted) | Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data. | Mean | Standard Deviation | %predicted |
| ||||||||||||||
| Residual Volume (RV) (liters) | Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data. | Mean | Standard Deviation | liters |
| ||||||||||||||
| Residual Volume (% predicted) | Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data. | Mean | Standard Deviation | %predicted |
| ||||||||||||||
| Total Lung Capacity (TLC) (liters) | Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data. | Mean | Standard Deviation | liters |
| ||||||||||||||
| Total Lung Capacity (% predicted) | Only 126 EBV subjects and 61 Control subjects were analyzed, due to missing data. | Mean | Standard Deviation | %predicted |
| ||||||||||||||
| GOLD Stage | The GOLD system uses the term "stages" to refer to the different levels of COPD. Participants graded as GOLD Stage III are considered to have Severe COPD. Participants graded as GOLD Stage IV are considered to have Very Severe COPD. | Count of Participants | Participants |
| |||||||||||||||
| 6 Minute Walk Distance (m) | Mean | Standard Deviation | meters |
| |||||||||||||||
| SGRQ Total score | The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations. | Only 127 EBV subjects and 61 Control subjects were analyzed, due to missing data. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| mMRC Dyspnea Grade score | The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations. | Only 126 EBV subjects were analyzed, due to missing data. | Mean | Standard Deviation | score |
| |||||||||||||
| BODE Index | The BODE Index is comprised of a person's body mass index ("B"), airway obstruction ("O"), dyspnea ("D"), and exercise tolerance ("E"). Each of these components is graded on a scale of either 0 to 1 or 0 to 3. The final value-ranging from 0 to 10-provides doctors a percentage of how likely a person is to survive for four years. The final BODE tabulation is described as follows: 0 to 2 points: 80 percent likelihood of survival 3 to 4 points: 67 percent likelihood of survival 5 of 6 points: 57 percent likelihood of survival 7 to 10 points: 18 percent likelihood of survival | Only 126 EBV subjects were analyzed, due to missing data. | Mean | Standard Deviation | Index |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Forced Expiratory Volume in 1-second (FEV1) | The percentage of study participants in the Zephyr Valve EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of >15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure. | Intent-to-Treat Population | Posted | Count of Participants | Participants | 1 year |
|
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| Secondary | FEV1 Post-bronchodilator Absolute Change | Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline). | Intent-to-treat | Posted | Mean | Standard Deviation | liters | 1 year |
| ||||||||||||||||||||||||||||||
| Secondary | St. George's Respiratory Questionnaire (SGRQ) | Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations. | Intent-to-treat | Posted | Mean | Standard Deviation | score on a scale | 1 year |
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| Secondary | 6-minute Walk Distance | Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline). | Intent-to-treat | Posted | Mean | Standard Deviation | meters | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zephyr Valve Treatment and Optimal Medical Management | This study arm will undergo The Zephyr Valve treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. EBV: This study arm will undergo Zephyr Valve treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. | 5 | 128 | 77 | 128 | 124 | 128 |
| EG001 | Optimal Medical Management | This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. Optimal Medical Management: This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. | 1 | 62 | 24 | 62 | 46 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Diverticular perforation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
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| Hernia | General disorders | MedDRA | Non-systematic Assessment |
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| Ulcer haemorrhage | General disorders | MedDRA | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Anaesthetic complication pulmonary | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Facial paralysis | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Guillain-Barre syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Device dislocation | Product Issues | MedDRA | Non-systematic Assessment |
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| Device expulsion | Product Issues | MedDRA | Non-systematic Assessment |
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| Alcohol abuse | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Umbilical hernia repair | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Narinder Shargill | Pulmonx Corporation | 650-216-0108 | nshargill@pulmonx.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2017 | Sep 6, 2018 | SAP_000.pdf |
| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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