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NCT05579782 · OUTCOME

Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 6 months after total thyroidectomy

What was measured

Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation.

Analysis population: We would not be able to provide precise data regarding duration and total daily dosage. Following surgery, those at risk for hypocalcemia are prescribed calcium standing dose and patients are also counseled to take additional calcium supplements. It is not possible to calculate an exact dose. Patients often take calcium supplements. Therefore, the additional calcium and the exact duration of when they stopped additional calcium is challenging for patients and was not collected in the trial.

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 (+)0
NIRAF Detection Technology (-)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation.
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 (-)
population Description
We would not be able to provide precise data regarding duration and total daily dosage. Following surgery, those at risk for hypocalcemia are prescribed calcium standing dose and patients are also counseled to take additional calcium supplements. It is not possible to calculate an exact dose. Patients often take calcium supplements. Therefore, the additional calcium and the exact duration of when they stopped additional calcium is challenging for patients and was not collected in the trial.
reporting Status
POSTED
time Frame
Up to 6 months after total thyroidectomy
title
Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery
type
SECONDARY

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

Preserved source evidence · Not medical advice