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NCT04281875 · BASELINE

Baseline characteristics

Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy. · Source last updated 2024-10-17

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 total thyroidectomy (TTx) with or without lymph node dissection (LND). 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 total thyroidectomy (TTx) with or without lymph node dissection (LND).
    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
          14.1
          value
          48.7
        2. group Id
          BG001
          spread
          14.5
          value
          46.4
        3. group Id
          BG002
          spread
          14.3
          value
          47.3
    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
          63
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          124
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          36
        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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          157
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          127
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          30
      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
          1
        3. group Id
          BG002
          value
          2
      title
      Other
    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
          8.8
          value
          31.9
        2. group Id
          BG001
          spread
          8.4
          value
          32.3
        3. group Id
          BG002
          spread
          8.6
          value
          32.1
    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
          25
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          50
      title
      Graves' Diseases
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
      title
      Goiters and Nodular Diseases
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          44
      title
      Thyroid Cancers
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.5
          value
          9.5
        2. group Id
          BG001
          spread
          0.4
          value
          9.4
        3. group Id
          BG002
          spread
          0.5
          value
          9.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative calcium (pg/dL)
    unit Of Measure
    pg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          28
          value
          62.6
        2. group Id
          BG001
          spread
          51.1
          value
          81.1
        3. group Id
          BG002
          spread
          40
          value
          71.3
    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
          13
          value
          29.5
        2. group Id
          BG001
          spread
          20.6
          value
          34.6
        3. group Id
          BG002
          spread
          17.1
          value
          32
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative vitamin D (mcg)
    unit Of Measure
    mcg
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          133
      title
      Total Thyroidectomy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          20
      title
      Total Thyroidectomy with Central Neck Dissection
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      Reoperation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Procedure
    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 total thyroidectomy (TTx) with or without lymph node dissection (LND). 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 total thyroidectomy (TTx) with or without lymph node dissection (LND).
    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
          14.1
          value
          48.7
        2. group Id
          BG001
          spread
          14.5
          value
          46.4
        3. group Id
          BG002
          spread
          14.3
          value
          47.3
    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
          63
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          124
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          36
        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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          157
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          127
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          30
      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
          1
        3. group Id
          BG002
          value
          2
      title
      Other
    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
          8.8
          value
          31.9
        2. group Id
          BG001
          spread
          8.4
          value
          32.3
        3. group Id
          BG002
          spread
          8.6
          value
          32.1
    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
          25
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          50
      title
      Graves' Diseases
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
      title
      Goiters and Nodular Diseases
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          44
      title
      Thyroid Cancers
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.5
          value
          9.5
        2. group Id
          BG001
          spread
          0.4
          value
          9.4
        3. group Id
          BG002
          spread
          0.5
          value
          9.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative calcium (pg/dL)
    unit Of Measure
    pg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          28
          value
          62.6
        2. group Id
          BG001
          spread
          51.1
          value
          81.1
        3. group Id
          BG002
          spread
          40
          value
          71.3
    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
          13
          value
          29.5
        2. group Id
          BG001
          spread
          20.6
          value
          34.6
        3. group Id
          BG002
          spread
          17.1
          value
          32
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative vitamin D (mcg)
    unit Of Measure
    mcg
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          133
      title
      Total Thyroidectomy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          20
      title
      Total Thyroidectomy with Central Neck Dissection
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      Reoperation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Procedure
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice