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NCT05579782 · OUTCOME

Number of Participants With Frozen Sections Sent for Analysis.

Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy · Source last updated 2025-07-31

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Immediate (during total thyroidectomy, up to 3 hours)

What was measured

Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue.

Groups in this outcome

NIRAF Detection Technology (+)

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. Other Name: PTeye Device

NIRAF Detection Technology (-)

Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
NIRAF Detection Technology (+)39
NIRAF Detection Technology (-)41

Reported measurements

Source class 1

0 frozen sections

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NIRAF Detection Technology (+)38Not reportedNot reportedNot reportedNot reported
NIRAF Detection Technology (-)30Not reportedNot reportedNot reportedNot reported

greater than or equal to 1 frozen sections

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NIRAF Detection Technology (+)1Not reportedNot reportedNot reportedNot reported
NIRAF Detection Technology (-)11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        30
      title
      0 frozen sections
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        11
      title
      greater than or equal to 1 frozen sections
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      41
    units
    Participants
description
Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue.
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. Other Name: PTeye Device
    id
    OG000
    title
    NIRAF Detection Technology (+)
  2. description
    Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
    id
    OG001
    title
    NIRAF Detection Technology (-)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Immediate (during total thyroidectomy, up to 3 hours)
title
Number of Participants With Frozen Sections Sent for Analysis.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice