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NCT04281875 · OUTCOME

Average Number of Parathyroid Glands Identified With High Confidence Per Patient

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.

Measure
MEAN
Unit
parathyroid glands
Interval / dispersion
Standard Deviation
Time frame
Immediate. During total thyroidectomy procedure.

What was measured

Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient

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.

NIRAF Detection Technology -

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).

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 +80
NIRAF Detection Technology -80

Reported measurements

Source class 1
Values in parathyroid glands · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
NIRAF Detection Technology +2.811.03Not reportedNot reportedNot reported
NIRAF Detection Technology -2.750.95Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6905
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6905
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.03
        value
        2.81
      2. group Id
        OG001
        spread
        0.95
        value
        2.75
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    2. group Id
      OG001
      value
      80
    units
    Participants
description
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
dispersion Type
Standard Deviation
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
    OG000
    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
    OG001
    title
    NIRAF Detection Technology -
param Type
MEAN
reporting Status
POSTED
time Frame
Immediate. During total thyroidectomy procedure.
title
Average Number of Parathyroid Glands Identified With High Confidence Per Patient
type
PRIMARY
unit Of Measure
parathyroid glands

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

Preserved source evidence · Not medical advice