ID

44113

Beschreibung

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.

Stichworte

Versionen (2)
  1. 07.09.19 07.09.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

PneumRx, Inc.

Hochgeladen am

20. September 2021

DOI

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Lizenz

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

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Unilateral/Bilateral Emphysema on CT

Datentyp

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?
Beschreibung

Homogeneous/Heterogeneous Emphysema on CT

Datentyp

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?
Beschreibung

Post-bronchodilator FEV1

Datentyp

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?
Beschreibung

Total Lung Capacity

Datentyp

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?
Beschreibung

Marked Dyspnea

Datentyp

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?
Beschreibung

Stopped Smoking

Datentyp

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
Beschreibung

Informed Consent

Datentyp

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
Beschreibung

Exclusion Criteria

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

Post-Bronchodliator FEV1 change

Datentyp

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?
Beschreibung

DLCO

Datentyp

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?
Beschreibung

Recurrent respiratory infection

Datentyp

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?
Beschreibung

Uncontrolled pulmonary hypertension

Datentyp

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?
Beschreibung

Severe inability to walk

Datentyp

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?
Beschreibung

Other survival-compromising disease

Datentyp

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?
Beschreibung

Pregnant or lactating

Datentyp

boolean

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

Inability to tolerate bronchoscopy under heavy sedation or anesthesia

Datentyp

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?
Beschreibung

Clinically significant bronchiectasis

Datentyp

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?
Beschreibung

Giant bullae

Datentyp

boolean

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

Previous LVR surgery, lung transplant or lobectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0524689
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?
Beschreibung

Recent pulmonary drug studies

Datentyp

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?
Beschreibung

Daily steroid dose

Datentyp

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?
Beschreibung

Clopidogrel status

Datentyp

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?
Beschreibung

Disease interfering with study

Datentyp

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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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
C0524689 (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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