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NCT05022667 · FLOW

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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.

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
    FG000
    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
    FG001
    title
    Standard of Care
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        57
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        57
      comment
      Participants were considered to have completed the trial if data was collected from them for the primary outcome measure.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
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
    FG000
    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
    FG001
    title
    Standard of Care
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        57
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        57
      comment
      Participants were considered to have completed the trial if data was collected from them for the primary outcome measure.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice