Participant flow

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.

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

   FG000

   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

   FG001

   title

   NIRAF Detection Technology (-)

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         41

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         41

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice