ID

38008

Beschrijving

The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.

Trefwoorden

Versies (2)
  1. 07-09-19 07-09-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

PneumRx, Inc.

Geüploaded op

7 september 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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RePneu Lung Volume Reduction Coil NCT01334307

Engels

Eligibility Criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Is the participant greater or equal to 35 years of age?
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have a high resolution CT scan that indicates unilateral or bilateral emphysema?
Beschrijving

Unilateral/Bilateral Emphysema on CT

Datatype

boolean

Alias
UMLS CUI [1,1]
C0412612
UMLS CUI [1,2]
C3508932
UMLS CUI [2,1]
C0412612
UMLS CUI [2,2]
C0034067
UMLS CUI [2,3]
C0238767
Does the participant have a high resolution CT scan that indicates homogeneous or heterogeneous emphysema?
Beschrijving

Homogeneous/Heterogeneous Emphysema on CT

Datatype

boolean

Alias
UMLS CUI [1,1]
C0412612
UMLS CUI [1,2]
C0439713
UMLS CUI [1,3]
C0034067
UMLS CUI [2,1]
C0412612
UMLS CUI [2,2]
C0019409
UMLS CUI [2,3]
C0034067
Does the participant have a post-bronchodilator FEV1 less than or equal to 45% predicted?
Beschrijving

Post-bronchodilator FEV1

Datatype

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C0849974
UMLS CUI [1,3]
C0439092
UMLS CUI [1,4]
C0681842
Does the participant have a Total Lung Capacity greater than 100% predicted?
Beschrijving

Total Lung Capacity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040509
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C0681842
Does the participant have a marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4?
Beschrijving

Marked Dyspnea

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706089
UMLS CUI [1,2]
C0013404
UMLS CUI [1,3]
C4055397
Does the participant have stopped smoking for a minimum of 8 weeks prior to entering the study?
Beschrijving

Stopped Smoking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0425310
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2603343
Does the participant (and legal guardian if applicable) have read, understood and signed the Informed Consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C0034754
UMLS CUI [1,3]
C0009797
UMLS CUI [2,1]
C0679646
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C0009797
UMLS CUI [3,1]
C0679646
UMLS CUI [3,2]
C1519316
UMLS CUI [3,3]
C0009797
UMLS CUI [4,1]
C0023226
UMLS CUI [4,2]
C0034754
UMLS CUI [4,3]
C0009797
UMLS CUI [5,1]
C0023226
UMLS CUI [5,2]
C0162340
UMLS CUI [5,3]
C0009797
UMLS CUI [6,1]
C0023226
UMLS CUI [6,2]
C1519316
UMLS CUI [6,3]
C0009797
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Does the participant have a change in FEV1 greater than 20% post-bronchodilator?
Beschrijving

Post-Bronchodliator FEV1 change

Datatype

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C0849974
UMLS CUI [1,3]
C4319952
UMLS CUI [1,4]
C0439093
Does the participant have a DLCO less than 20% predicted?
Beschrijving

DLCO

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516251
UMLS CUI [1,2]
C0439092
UMLS CUI [1,3]
C0681842
Does the participant have a history of recurrent clinically significant respiratory infection?
Beschrijving

Recurrent respiratory infection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0035243
UMLS CUI [1,4]
C2945760
Does the participant have a uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram?
Beschrijving

Uncontrolled pulmonary hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C2023445
UMLS CUI [2,2]
C0439093
Does the participant have an inability to walk greater than 140 meters (150 yards) in 6 minutes?
Beschrijving

Severe inability to walk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0560046
UMLS CUI [1,2]
C1548772
Does the participant have evidence of other disease that may compromise survival such as lung cancer, renal failure, etc?
Beschrijving

Other survival-compromising disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0038952
UMLS CUI [2]
C0684249
UMLS CUI [3]
C0035078
Is the participant pregnant or lactating?
Beschrijving

Pregnant or lactating

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2828358
Does the participant have an inability to tolerate bronchoscopy under heavy sedation or anesthesia?
Beschrijving

Inability to tolerate bronchoscopy under heavy sedation or anesthesia

Datatype

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C1704410
UMLS CUI [1,3]
C0006290
UMLS CUI [1,4]
C4723618
UMLS CUI [1,5]
C0235195
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C1704410
UMLS CUI [2,3]
C0006290
UMLS CUI [2,4]
C0002903
Does the participant have clinically significant bronchiectasis?
Beschrijving

Clinically significant bronchiectasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0006267
Does the participant have a giant bullae greater than 1/3 lung volume?
Beschrijving

Giant bullae

Datatype

boolean

Alias
UMLS CUI [1,1]
C0549177
UMLS CUI [1,2]
C0241982
Does the participant had previous LVR surgery, lung transplant or lobectomy?
Beschrijving

Previous LVR surgery, lung transplant or lobectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0375931
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C0024128
UMLS CUI [3,1]
C0205156
UMLS CUI [3,2]
C0023928
Does the participant have been involved in other pulmonary drug studies with 30 days prior to this study?
Beschrijving

Recent pulmonary drug studies

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C0024109
UMLS CUI [1,5]
C1254351
Is the participant taking greater than 20 mg prednisone (or similar steroid) daily?
Beschrijving

Daily steroid dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439093
Is the participant on Plavix or has not been weaned off prior to procedure?
Beschrijving

Clopidogrel status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0070166
UMLS CUI [1,2]
C0457083
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0184661
Does the participant have other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes?
Beschrijving

Disease interfering with study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348557
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C1522577
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C1274040
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Similar models

Eligibility Criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Is the participant greater or equal to 35 years of age?
boolean
C0001779 (UMLS CUI [1])
Unilateral/Bilateral Emphysema on CT
Item
Does the participant have a high resolution CT scan that indicates unilateral or bilateral emphysema?
boolean
C0412612 (UMLS CUI [1,1])
C3508932 (UMLS CUI [1,2])
C0412612 (UMLS CUI [2,1])
C0034067 (UMLS CUI [2,2])
C0238767 (UMLS CUI [2,3])
Homogeneous/Heterogeneous Emphysema on CT
Item
Does the participant have a high resolution CT scan that indicates homogeneous or heterogeneous emphysema?
boolean
C0412612 (UMLS CUI [1,1])
C0439713 (UMLS CUI [1,2])
C0034067 (UMLS CUI [1,3])
C0412612 (UMLS CUI [2,1])
C0019409 (UMLS CUI [2,2])
C0034067 (UMLS CUI [2,3])
Post-bronchodilator FEV1
Item
Does the participant have a post-bronchodilator FEV1 less than or equal to 45% predicted?
boolean
C2599594 (UMLS CUI [1,1])
C0849974 (UMLS CUI [1,2])
C0439092 (UMLS CUI [1,3])
C0681842 (UMLS CUI [1,4])
Total Lung Capacity
Item
Does the participant have a Total Lung Capacity greater than 100% predicted?
boolean
C0040509 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C0681842 (UMLS CUI [1,3])
Marked Dyspnea
Item
Does the participant have a marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4?
boolean
C1706089 (UMLS CUI [1,1])
C0013404 (UMLS CUI [1,2])
C4055397 (UMLS CUI [1,3])
Stopped Smoking
Item
Does the participant have stopped smoking for a minimum of 8 weeks prior to entering the study?
boolean
C0425310 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
Informed Consent
Item
Does the participant (and legal guardian if applicable) have read, understood and signed the Informed Consent form
boolean
C0679646 (UMLS CUI [1,1])
C0034754 (UMLS CUI [1,2])
C0009797 (UMLS CUI [1,3])
C0679646 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C0009797 (UMLS CUI [2,3])
C0679646 (UMLS CUI [3,1])
C1519316 (UMLS CUI [3,2])
C0009797 (UMLS CUI [3,3])
C0023226 (UMLS CUI [4,1])
C0034754 (UMLS CUI [4,2])
C0009797 (UMLS CUI [4,3])
C0023226 (UMLS CUI [5,1])
C0162340 (UMLS CUI [5,2])
C0009797 (UMLS CUI [5,3])
C0023226 (UMLS CUI [6,1])
C1519316 (UMLS CUI [6,2])
C0009797 (UMLS CUI [6,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Post-Bronchodliator FEV1 change
Item
Does the participant have a change in FEV1 greater than 20% post-bronchodilator?
boolean
C2599594 (UMLS CUI [1,1])
C0849974 (UMLS CUI [1,2])
C4319952 (UMLS CUI [1,3])
C0439093 (UMLS CUI [1,4])
DLCO
Item
Does the participant have a DLCO less than 20% predicted?
boolean
C1516251 (UMLS CUI [1,1])
C0439092 (UMLS CUI [1,2])
C0681842 (UMLS CUI [1,3])
Recurrent respiratory infection
Item
Does the participant have a history of recurrent clinically significant respiratory infection?
boolean
C0262926 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0035243 (UMLS CUI [1,3])
C2945760 (UMLS CUI [1,4])
Uncontrolled pulmonary hypertension
Item
Does the participant have a uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram?
boolean
C0020542 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2023445 (UMLS CUI [2,1])
C0439093 (UMLS CUI [2,2])
Severe inability to walk
Item
Does the participant have an inability to walk greater than 140 meters (150 yards) in 6 minutes?
boolean
C0560046 (UMLS CUI [1,1])
C1548772 (UMLS CUI [1,2])
Other survival-compromising disease
Item
Does the participant have evidence of other disease that may compromise survival such as lung cancer, renal failure, etc?
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0038952 (UMLS CUI [1,4])
C0684249 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
Pregnant or lactating
Item
Is the participant pregnant or lactating?
boolean
C0032961 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Inability to tolerate bronchoscopy under heavy sedation or anesthesia
Item
Does the participant have an inability to tolerate bronchoscopy under heavy sedation or anesthesia?
boolean
C1299582 (UMLS CUI [1,1])
C1704410 (UMLS CUI [1,2])
C0006290 (UMLS CUI [1,3])
C4723618 (UMLS CUI [1,4])
C0235195 (UMLS CUI [1,5])
C1299582 (UMLS CUI [2,1])
C1704410 (UMLS CUI [2,2])
C0006290 (UMLS CUI [2,3])
C0002903 (UMLS CUI [2,4])
Clinically significant bronchiectasis
Item
Does the participant have clinically significant bronchiectasis?
boolean
C2985739 (UMLS CUI [1,1])
C0006267 (UMLS CUI [1,2])
Giant bullae
Item
Does the participant have a giant bullae greater than 1/3 lung volume?
boolean
C0549177 (UMLS CUI [1,1])
C0241982 (UMLS CUI [1,2])
Previous LVR surgery, lung transplant or lobectomy
Item
Does the participant had previous LVR surgery, lung transplant or lobectomy?
boolean
C0205156 (UMLS CUI [1,1])
C0375931 (UMLS CUI [1,2])
C0205156 (UMLS CUI [2,1])
C0024128 (UMLS CUI [2,2])
C0205156 (UMLS CUI [3,1])
C0023928 (UMLS CUI [3,2])
Recent pulmonary drug studies
Item
Does the participant have been involved in other pulmonary drug studies with 30 days prior to this study?
boolean
C0332185 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0024109 (UMLS CUI [1,4])
C1254351 (UMLS CUI [1,5])
Daily steroid dose
Item
Is the participant taking greater than 20 mg prednisone (or similar steroid) daily?
boolean
C0032952 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439093 (UMLS CUI [1,3])
Clopidogrel status
Item
Is the participant on Plavix or has not been weaned off prior to procedure?
boolean
C0070166 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
Disease interfering with study
Item
Does the participant have other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes?
boolean
C0205394 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348557 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C1522577 (UMLS CUI [2,4])
C0205394 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1274040 (UMLS CUI [3,4])
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