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Study enrollment was prematurely stopped.
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| Name | Class |
|---|---|
| PneumRx, Inc. | INDUSTRY |
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The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu Coils, when used as intended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Patients treated with PneumRx Coil System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PneumRx Coil System | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 6 Minute Walk Distance (6MWD) | Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters. | Baseline, 12 months post initial treatment |
| Changes in 6 Minute Walk Distance (6MWD) | Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters. | Baseline, 3 months post final treatment |
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Inclusion Criteria:
Exclusion Criteria:
Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g. severe arthritis, planned knee surgery) or baseline limitation not due to dyspnea.
Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
Subject has severe gas exchange abnormalities as defined by:
Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
Subject has clinically significant bronchiectasis.
Subject has had previous LVR surgery, lung transplantation, lobectomy or other BLVR treatment in either lung.
Subject has participated in studies to treat COPD using high dose radiation.
Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
Subject is chronically taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
Subject is on any type of antiplatelet or anticoagulant therapy which cannot be stopped for seven (7) days prior to procedure.
Subject has a sensitivity or allergy to Nickel.
Subject has a known sensitivity to drugs required to perform bronchoscopy.
Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).
Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow-up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
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Adult subjects diagnosed with emphysematous type of COPD
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lungenclinic | Großhansdorf | Germany | ||||
| Thoraxklinik |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Patients treated with PneumRx Coil System PneumRx Coil System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Patients treated with PneumRx Coil System PneumRx Coil System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Changes in 6 Minute Walk Distance (6MWD) | Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters. | Intention to treat population with 6MWT data available at baseline and 12 months | Posted | Mean | Standard Deviation | meters | Baseline, 12 months post initial treatment |
|
|
12 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 | Treatment | Patients treated with PneumRx Coil System | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Condition aggravated | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jörg Rennecke | PneumRx | +49 211 5422750 | medical.services@btgplc.com |
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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 | Aug 19, 2014 | Mar 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2018 | Mar 8, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Heidelberg |
| Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Changes in 6 Minute Walk Distance (6MWD) | Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters. | Intention to treat population with 6MWT data available at baseline and 3 months | Posted | Mean | Standard Deviation | meters | Baseline, 3 months post final treatment |
|
|
|
| 20 |
| 10 |
| 20 |
| 16 |
| 20 |
| Implant site reaction | General disorders | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
|
| Infective exacerbation of chronic obstructive pulmonary disorders | Infections and infestations | Systematic Assessment |
|
| Post procedural pneumonia | Infections and infestations | Systematic Assessment |
|
| Fibrocystic breast disease | Reproductive system and breast disorders | Systematic Assessment |
|
| Chronic obstructive pulmonary disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tendon Rupture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | Systematic Assessment |
|
| Infective Exacerbation of Chronic Obstructive Airways Disease | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia Bacterial | Infections and infestations | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chest Discomfort | General disorders | Systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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