NCT05022667 · OUTCOME

Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery

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.

Measure: MEAN
Unit: pg/mL
Interval / dispersion: Standard Deviation
Time frame: Within 24-48 hours after surgery

What was measured

Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery

Analysis population: Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected.

Groups in this outcome

PTeye

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.

Standard of Care

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.

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

Analysis denominator · Participants

Group	Source count
PTeye	56
Standard of Care	52

Reported measurements

Source class 1

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
PTeye	20.7	11.6	Not reported	Not reported	Not reported
Standard of Care	24.3	16.6	Not reported	Not reported	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
.2
statistical Method
t-test, 2 sided

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
.2
statistical Method
t-test, 2 sided

classes

categories
measurements
group Id
OG000
spread
11.6
value
20.7
group Id
OG001
spread
16.6
value
24.3

denoms

counts
group Id
OG000
value
56
group Id
OG001
value
52
units
Participants

description

Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery

dispersion Type

Standard Deviation

groups

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
OG000
title
PTeye
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
OG001
title
Standard of Care

param Type

MEAN

population Description

Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected.

reporting Status

POSTED

time Frame

Within 24-48 hours after surgery

title

Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery

type

SECONDARY

unit Of Measure

pg/mL

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

Preserved source evidence · Not medical advice