ID

36597

Beskrivning

Powered Surgical Stapler in VATS Lung Resection Procedures in China; ODM derived from: https://clinicaltrials.gov/show/NCT02338583

Länk

https://clinicaltrials.gov/show/NCT02338583

Nyckelord

Versioner (1)
  1. 2019-05-25 2019-05-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer (NSCLC) NCT02338583

Engelsk

Eligibility Non-small Cell Lung Cancer (NSCLC) NCT02338583

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc);
Beskrivning

Non-Small Cell Lung Carcinoma Suspected TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging | Wedge resection VATS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0184909
UMLS CUI [3,2]
C0752151
2. scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
Beskrivning

Lung excision Scheduled | Lung excision Involving Lobe of lung Quantity | Lobectomy | Wedge resection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0396565
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0396565
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0225752
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0023928
UMLS CUI [4]
C0184909
3. performance status 0-1 (eastern cooperative oncology group classification);
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. asa score < 3;
Beskrivning

American Society of Anesthesiologists physical status classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1531480
5. no prior history of vats or open lung surgery;
Beskrivning

Video-Assisted Thoracic Surgery Absent | Open Surgical Procedure Lung Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0752151
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C4283938
UMLS CUI [2,2]
C0024109
UMLS CUI [2,3]
C0332197
6. willing to give consent and comply with study-related evaluation and treatment schedule; and
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
7. at least 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects satisfying the following criteria will be eligible for participation in this study:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc);
Beskrivning

Non-Small Cell Lung Carcinoma Suspected TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging | Wedge resection VATS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0184909
UMLS CUI [3,2]
C0752151
2. scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
Beskrivning

Lung excision Scheduled | Lung excision Involving Lobe of lung Quantity | Lobectomy | Wedge resection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0396565
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0396565
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0225752
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0023928
UMLS CUI [4]
C0184909
3. performance status 0-1 (eastern cooperative oncology group classification);
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. asa score < 3;
Beskrivning

American Society of Anesthesiologists physical status classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1531480
5. no prior history of vats or open lung surgery;
Beskrivning

Video-Assisted Thoracic Surgery Absent | Open Surgical Procedure Lung Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0752151
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C4283938
UMLS CUI [2,2]
C0024109
UMLS CUI [2,3]
C0332197
6. willing to give consent and comply with study-related evaluation and treatment schedule; and
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
7. at least 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Non-small Cell Lung Cancer (NSCLC) NCT02338583

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Suspected TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging | Wedge resection VATS
Item
1. suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc);
boolean
C0007131 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0184909 (UMLS CUI [3,1])
C0752151 (UMLS CUI [3,2])
Lung excision Scheduled | Lung excision Involving Lobe of lung Quantity | Lobectomy | Wedge resection
Item
2. scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
boolean
C0396565 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0396565 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0225752 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0023928 (UMLS CUI [3])
C0184909 (UMLS CUI [4])
ECOG performance status
Item
3. performance status 0-1 (eastern cooperative oncology group classification);
boolean
C1520224 (UMLS CUI [1])
American Society of Anesthesiologists physical status classification
Item
4. asa score < 3;
boolean
C1531480 (UMLS CUI [1])
Video-Assisted Thoracic Surgery Absent | Open Surgical Procedure Lung Absent
Item
5. no prior history of vats or open lung surgery;
boolean
C0752151 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4283938 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
6. willing to give consent and comply with study-related evaluation and treatment schedule; and
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Age
Item
7. at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
subjects satisfying the following criteria will be eligible for participation in this study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma Suspected TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging | Wedge resection VATS
Item
1. suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc);
boolean
C0007131 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0184909 (UMLS CUI [3,1])
C0752151 (UMLS CUI [3,2])
Lung excision Scheduled | Lung excision Involving Lobe of lung Quantity | Lobectomy | Wedge resection
Item
2. scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
boolean
C0396565 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0396565 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0225752 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0023928 (UMLS CUI [3])
C0184909 (UMLS CUI [4])
ECOG performance status
Item
3. performance status 0-1 (eastern cooperative oncology group classification);
boolean
C1520224 (UMLS CUI [1])
American Society of Anesthesiologists physical status classification
Item
4. asa score < 3;
boolean
C1531480 (UMLS CUI [1])
Video-Assisted Thoracic Surgery Absent | Open Surgical Procedure Lung Absent
Item
5. no prior history of vats or open lung surgery;
boolean
C0752151 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4283938 (UMLS CUI [2,1])
C0024109 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
6. willing to give consent and comply with study-related evaluation and treatment schedule; and
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Age
Item
7. at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
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