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NCT05022667 · BASELINE

Baseline characteristics

Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy · Source last updated 2025-08-08

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
      57
    2. group Id
      BG001
      value
      57
    3. group Id
      BG002
      value
      114
    units
    Participants
groups
  1. description
    The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
    id
    BG000
    title
    PTeye
  2. description
    The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.9
          value
          51.2
        2. group Id
          BG001
          spread
          16
          value
          52.6
        3. group Id
          BG002
          spread
          16.4
          value
          51.9
    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
          44
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          87
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          109
        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
          47
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          96
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      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
          57
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          114
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.5
          value
          9.4
        2. group Id
          BG001
          spread
          0.4
          value
          9.5
        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)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          22.4
          value
          48.2
        2. group Id
          BG001
          spread
          25
          value
          78.3
        3. group Id
          BG002
          spread
          27.9
          value
          64.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative PTH (pg/mL)
    unit Of Measure
    (pg/mL)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.6
          value
          33
        2. group Id
          BG001
          spread
          11
          value
          29.3
        3. group Id
          BG002
          spread
          12
          value
          30.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative vitamin D (mcg)
    unit Of Measure
    mcg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          33
        title
        Grave's disease
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        title
        Goiters and nodular diseases
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          62
        title
        Thyroid cancer
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Final Diagnosis
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      57
    2. group Id
      BG001
      value
      57
    3. group Id
      BG002
      value
      114
    units
    Participants
groups
  1. description
    The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
    id
    BG000
    title
    PTeye
  2. description
    The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.9
          value
          51.2
        2. group Id
          BG001
          spread
          16
          value
          52.6
        3. group Id
          BG002
          spread
          16.4
          value
          51.9
    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
          44
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          87
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          109
        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
          47
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          96
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      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
          57
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          114
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.5
          value
          9.4
        2. group Id
          BG001
          spread
          0.4
          value
          9.5
        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)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          22.4
          value
          48.2
        2. group Id
          BG001
          spread
          25
          value
          78.3
        3. group Id
          BG002
          spread
          27.9
          value
          64.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative PTH (pg/mL)
    unit Of Measure
    (pg/mL)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.6
          value
          33
        2. group Id
          BG001
          spread
          11
          value
          29.3
        3. group Id
          BG002
          spread
          12
          value
          30.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Preoperative vitamin D (mcg)
    unit Of Measure
    mcg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          33
        title
        Grave's disease
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        title
        Goiters and nodular diseases
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          62
        title
        Thyroid cancer
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Final Diagnosis
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice