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ID

37039

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02399124

Keywords

versioni (1)
  1. 01/07/19 01/07/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

1 luglio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Renal Cell Carcinoma NCT02399124

    Inglese

    Eligibility Renal Cell Carcinoma NCT02399124

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

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

    Age

    Tipo di dati

    boolean

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

    Renal mass | Renal Cell Carcinoma Biopsy

    Tipo di dati

    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.
    Descrizione

    Renal mass Visualization CT

    Tipo di dati

    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.
    Descrizione

    Renal mass Peripheral | Renal mass Location Cortex of kidney

    Tipo di dati

    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.
    Descrizione

    Renal mass Size Dimension Largest

    Tipo di dati

    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.
    Descrizione

    Patient Able Clinic Visit | Follow-up Post Cryosurgery

    Tipo di dati

    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.
    Descrizione

    Informed Consent | Authorization Privacy of Patient Data

    Tipo di dati

    boolean

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

    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.
    Descrizione

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

    Tipo di dati

    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.
    Descrizione

    Renal mass Metastasis Stage

    Tipo di dati

    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.
    Descrizione

    Blood Coagulation Disorders Permanent | Unstable status Medical Severe | Sepsis

    Tipo di dati

    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.
    Descrizione

    Terminal illness

    Tipo di dati

    boolean

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

    Communicable Diseases | Tuberculosis | Hepatitis | AIDS

    Tipo di dati

    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.
    Descrizione

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

    Tipo di dati

    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 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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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