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NCT04299425 · BASELINE

Baseline characteristics

Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy · Source last updated 2024-05-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      80
    2. group Id
      BG001
      value
      80
    3. group Id
      BG002
      value
      160
    units
    Participants
groups
  1. description
    Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
    id
    BG000
    title
    NIRAF Detection Technology +
  2. description
    Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
    id
    BG001
    title
    NIRAF Detection Technology -
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.6
          value
          56.8
        2. group Id
          BG001
          spread
          14.4
          value
          59.8
        3. group Id
          BG002
          spread
          14.5
          value
          58.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          125
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          35
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          147
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          159
      title
      Non-Hispanic
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Hispanic
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          160
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.52
          value
          30.77
        2. group Id
          BG001
          spread
          7.72
          value
          30.94
        3. group Id
          BG002
          spread
          7.59
          value
          30.85
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          143
        title
        Primary sporadic HPT
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
        title
        Persistent HPT
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Recurrent HPT
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        MEN1
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Parathyroid carcinoma
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Lithium-induced HPT
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.689
          value
          11.115
        2. group Id
          BG001
          spread
          0.712
          value
          11.112
        3. group Id
          BG002
          spread
          0.712
          value
          11.112
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative calcium (pg/dL)
    unit Of Measure
    mg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          79.8
          value
          152.3
        2. group Id
          BG001
          spread
          139
          value
          163.6
        3. group Id
          BG002
          spread
          112.7
          value
          157.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative PTH (pg/mL)
    unit Of Measure
    pg/mL
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16
          value
          36.7
        2. group Id
          BG001
          spread
          20.5
          value
          39.6
        3. group Id
          BG002
          spread
          18.2
          value
          38.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative vitamin D
    unit Of Measure
    mcg
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          51
        title
        Focused
      2. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          109
        title
        Bilateral
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Procedure by intention
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      80
    2. group Id
      BG001
      value
      80
    3. group Id
      BG002
      value
      160
    units
    Participants
groups
  1. description
    Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
    id
    BG000
    title
    NIRAF Detection Technology +
  2. description
    Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
    id
    BG001
    title
    NIRAF Detection Technology -
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.6
          value
          56.8
        2. group Id
          BG001
          spread
          14.4
          value
          59.8
        3. group Id
          BG002
          spread
          14.5
          value
          58.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          125
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          35
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          147
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          159
      title
      Non-Hispanic
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Hispanic
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          160
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.52
          value
          30.77
        2. group Id
          BG001
          spread
          7.72
          value
          30.94
        3. group Id
          BG002
          spread
          7.59
          value
          30.85
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          143
        title
        Primary sporadic HPT
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
        title
        Persistent HPT
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Recurrent HPT
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        MEN1
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Parathyroid carcinoma
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Lithium-induced HPT
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.689
          value
          11.115
        2. group Id
          BG001
          spread
          0.712
          value
          11.112
        3. group Id
          BG002
          spread
          0.712
          value
          11.112
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative calcium (pg/dL)
    unit Of Measure
    mg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          79.8
          value
          152.3
        2. group Id
          BG001
          spread
          139
          value
          163.6
        3. group Id
          BG002
          spread
          112.7
          value
          157.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative PTH (pg/mL)
    unit Of Measure
    pg/mL
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16
          value
          36.7
        2. group Id
          BG001
          spread
          20.5
          value
          39.6
        3. group Id
          BG002
          spread
          18.2
          value
          38.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative vitamin D
    unit Of Measure
    mcg
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          51
        title
        Focused
      2. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          109
        title
        Bilateral
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Procedure by intention
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice