ID

37039

Beskrivning

Post Marketing Surveillance for ICE-SENSE™3 a Cryotherapy Treatment of Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02399124

Länk

https://clinicaltrials.gov/show/NCT02399124

Nyckelord

Versioner (1)
  1. 2019-07-01 2019-07-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT02399124

Engelsk

Eligibility Renal Cell Carcinoma NCT02399124

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient is above 18 years old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient has kidney mass proven to be rcc by biopsy
Beskrivning

Renal mass | Renal Cell Carcinoma Biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0262613
UMLS CUI [2,1]
C0007134
UMLS CUI [2,2]
C0005558
3. patient's renal mass can be visualized using ct.
Beskrivning

Renal mass Visualization CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262613
UMLS CUI [1,2]
C0596820
UMLS CUI [1,3]
C0040405
4. patient's renal mass is peripheral and located on the kidney cortex.
Beskrivning

Renal mass Peripheral | Renal mass Location Cortex of kidney

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262613
UMLS CUI [1,2]
C0205100
UMLS CUI [2,1]
C0262613
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0022655
5. patient's renal mass size is between 0.5 cm and 3 cm at its largest dimension.
Beskrivning

Renal mass Size Dimension Largest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262613
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0439534
UMLS CUI [1,4]
C0443228
6. patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure.
Beskrivning

Patient Able Clinic Visit | Follow-up Post Cryosurgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0008952
UMLS CUI [2,1]
C1522577
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0010408
7. the patient has been informed of the study and agrees to its provisions, and has signed an irb approved written informed consent, including data privacy authorization.
Beskrivning

Informed Consent | Authorization Privacy of Patient Data

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0680281
UMLS CUI [2,2]
C0030684
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient with hilary renal mass or one that is located next to a large blood vessel or adjacently to the collection system and upper ureter.
Beskrivning

Renal mass Hilum of kidney | Renal mass Location next to Large blood vessel | Renal mass Location Adjacent Upper third of ureter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262613
UMLS CUI [1,2]
C0227608
UMLS CUI [2,1]
C0262613
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0205117
UMLS CUI [2,4]
C0225990
UMLS CUI [3,1]
C0262613
UMLS CUI [3,2]
C1515974
UMLS CUI [3,3]
C0205117
UMLS CUI [3,4]
C0447578
2. patient with renal mass in metastasis stage.
Beskrivning

Renal mass Metastasis Stage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262613
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C1306673
3. patients with permanent coagulation disorders or severe medical instability such as sepsis.
Beskrivning

Blood Coagulation Disorders Permanent | Unstable status Medical Severe | Sepsis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205355
UMLS CUI [2,1]
C0443343
UMLS CUI [2,2]
C0205476
UMLS CUI [2,3]
C0205082
UMLS CUI [3]
C0243026
4. patients with any terminal illness.
Beskrivning

Terminal illness

Datatyp

boolean

Alias
UMLS CUI [1]
C0679247
5. patients carrying contagious diseases such as tuberculosis hepatitis or aids.
Beskrivning

Communicable Diseases | Tuberculosis | Hepatitis | AIDS

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0041296
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0001175
6. patient participating in other trials using drugs or devices.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Renal Cell Carcinoma NCT02399124

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient is above 18 years old.
boolean
C0001779 (UMLS CUI [1])
Renal mass | Renal Cell Carcinoma Biopsy
Item
2. patient has kidney mass proven to be rcc by biopsy
boolean
C0262613 (UMLS CUI [1])
C0007134 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Renal mass Visualization CT
Item
3. patient's renal mass can be visualized using ct.
boolean
C0262613 (UMLS CUI [1,1])
C0596820 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
Renal mass Peripheral | Renal mass Location Cortex of kidney
Item
4. patient's renal mass is peripheral and located on the kidney cortex.
boolean
C0262613 (UMLS CUI [1,1])
C0205100 (UMLS CUI [1,2])
C0262613 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0022655 (UMLS CUI [2,3])
Renal mass Size Dimension Largest
Item
5. patient's renal mass size is between 0.5 cm and 3 cm at its largest dimension.
boolean
C0262613 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0439534 (UMLS CUI [1,3])
C0443228 (UMLS CUI [1,4])
Patient Able Clinic Visit | Follow-up Post Cryosurgery
Item
6. patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure.
boolean
C0030705 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0010408 (UMLS CUI [2,3])
Informed Consent | Authorization Privacy of Patient Data
Item
7. the patient has been informed of the study and agrees to its provisions, and has signed an irb approved written informed consent, including data privacy authorization.
boolean
C0021430 (UMLS CUI [1])
C0680281 (UMLS CUI [2,1])
C0030684 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Renal mass Hilum of kidney | Renal mass Location next to Large blood vessel | Renal mass Location Adjacent Upper third of ureter
Item
1. patient with hilary renal mass or one that is located next to a large blood vessel or adjacently to the collection system and upper ureter.
boolean
C0262613 (UMLS CUI [1,1])
C0227608 (UMLS CUI [1,2])
C0262613 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0205117 (UMLS CUI [2,3])
C0225990 (UMLS CUI [2,4])
C0262613 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C0205117 (UMLS CUI [3,3])
C0447578 (UMLS CUI [3,4])
Renal mass Metastasis Stage
Item
2. patient with renal mass in metastasis stage.
boolean
C0262613 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
Blood Coagulation Disorders Permanent | Unstable status Medical Severe | Sepsis
Item
3. patients with permanent coagulation disorders or severe medical instability such as sepsis.
boolean
C0005779 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C0443343 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0243026 (UMLS CUI [3])
Terminal illness
Item
4. patients with any terminal illness.
boolean
C0679247 (UMLS CUI [1])
Communicable Diseases | Tuberculosis | Hepatitis | AIDS
Item
5. patients carrying contagious diseases such as tuberculosis hepatitis or aids.
boolean
C0009450 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0001175 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
6. patient participating in other trials using drugs or devices.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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