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| Name | Class |
|---|---|
| PneumRx, Inc. | INDUSTRY |
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This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.
This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endobronchial Coils | Experimental | Treatment with PneumRx Endobronchial Coil System |
|
| Control | No Intervention | Medically-managed control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobronchial Coils | Device | Endobronchial Coil implants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in FEV1 at 6 Months | Percent change in FEV1 | 6 months |
| Absolute Change in SGRQ Score at 6 Months | Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Herth, MD, | University Hospital Heidelberg | Principal Investigator |
| Arschang Valipour, MD,FCCP,PhD | Nord-Klinik Floridsdorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie | Vienna | Austria | ||||
| CHU Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33590989 | Derived | Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endobronchial Coils | Treatment with PneumRx Endobronchial Coil System Endobronchial Coils: Endobronchial Coil implants |
| FG001 | Control | Medically-managed control group |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2020 |
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| Grenoble |
| France |
| CHU Montpellier | Montpellier | France |
| Centre Hospitalier Universitaire de Nice | Nice | CS 51069 | France |
| Hôpital Bichat | Paris | France |
| CHU de Reims - Hopital Maison Blanche | Reims | 51092 | France |
| Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie | Berlin | Germany |
| Gemeinschaftskrankenhaus Havelhöhe GmbH | Berlin | Germany |
| Universitätsklinkum Bonn | Bonn | Germany |
| Ruhrlandklinik Essen | Essen | Germany |
| Thoraxklinik | Heidelberg | Germany |
| Lungenklinik | Hemer | Germany |
| Lungenfachklinik Immenhausen | Immenhausen | 34376 | Germany |
| Klinikverbund Kempten-Oberallgäu | Immenstädt | Germany |
| Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH | Stuttgart | Germany |
| Ospedale Careggi | Florence | Italy |
| University Medical Center Groningen | Groningen | 3150-3610536 | Netherlands |
| Royal Brompton Hospital | London | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Endobronchial Coils | Treatment with PneumRx Endobronchial Coil System Endobronchial Coils: Endobronchial Coil implants |
| BG001 | Control | Medically-managed control group |
| 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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| Forced Expiratory Volume in 1 second (FEV1) | Mean | Standard Deviation | Litres |
| |||||||||||||||
| St. George Respiratory Questionnaire Score (SGRQ) | Mean | Standard Deviation | units on a scale |
|
| 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 | Percent Change in FEV1 at 6 Months | Percent change in FEV1 | Posted | Mean | Standard Deviation | percent change from baseline | 6 months |
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| Primary | Absolute Change in SGRQ Score at 6 Months | Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Post-Hoc | 36 Month Follow Up Visit Completion for French Participants (N=46) | Number of French participants who received treatment with Endobronchial Coil System (randomized and crossover participants) that completed the 36 month follow up visit. All control participants who exited after 6 months are excluded for this outcome. | Global study was terminated early; however, French Authorities required French participants to be followed through 36-months for safety only. Only subjects that received treatment with Endobronchial Coil System (randomized and crossover control participants) are included in this outcome. | Posted | Number | participants | 36 months |
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| Post-Hoc | Crude Mortality for French Participants (N=46) | Number of deaths for French participants through 36 months. All control participants who exited after 6 months are excluded for this outcome. | Global study was terminated early; however, French Authorities required French participants to be followed through 36-months for safety only. | Posted | Count of Participants | Participants | 36 months |
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6 months
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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 | Endobronchial Coils | Treatment with PneumRx Endobronchial Coil System Endobronchial Coils: Endobronchial Coil implants | 5 | 73 | 30 | 73 | 39 | 73 |
| EG001 | Control | Medically-managed control group | 0 | 40 | 3 | 40 | 12 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Enterococcal infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| urosepsis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| infective exacerbation of COPD | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Dypsnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hypercapnea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
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| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
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| renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
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| atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| constipation | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| death | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| device dislocation | Product Issues | MedDRA 22.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Haemorrhage | Ear and labyrinth disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Gastrointestinal Tract Irritation | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| bronchitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Infected Dermal Cyst | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Lung Infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Oral Candidiasis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Tooth Abscess | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Tooth Infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pulmonary Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Stockwell | Boston Scientific Corporation | 612-618-1136 | Jessie.Stockwell@bsci.com |
| Apr 12, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months. |
Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months. |
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