NCT05022641 · OUTCOME

Appropriate Intraoperative Parathyroid Hormone Drop

Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy · Source last updated 2025-08-27

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: baseline to 10 minutes

What was measured

\>50% drop from baseline at 10 minutes post-resection

Analysis population: Some participants' data was not collected by the surgeons during the baseline-to-10-minute time frame.

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 parathyroid surgery. 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 (see Figure 1), as per device functionality requirements.

Standard of Care

The surgeon will rely 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	80
Standard of Care	75

Reported measurements

Source class 1

Yes

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PTeye	45	Not reported	Not reported	Not reported	Not reported
Standard of Care	56	Not reported	Not reported	Not reported	Not reported

No

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
PTeye	35	Not reported	Not reported	Not reported	Not reported
Standard of Care	19	Not reported	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
.02
statistical Method
Chi-squared

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
.02
statistical Method
Chi-squared

classes

categories
measurements
group Id
OG000
value
45
group Id
OG001
value
56
title
Yes
measurements
group Id
OG000
value
35
group Id
OG001
value
19
title
No

denoms

counts
group Id
OG000
value
80
group Id
OG001
value
75
units
Participants

description

\>50% drop from baseline at 10 minutes post-resection

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 parathyroid surgery. 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 (see Figure 1), as per device functionality requirements.
id
OG000
title
PTeye
description
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
id
OG001
title
Standard of Care

param Type

COUNT_OF_PARTICIPANTS

population Description

Some participants' data was not collected by the surgeons during the baseline-to-10-minute time frame.

reporting Status

POSTED

time Frame

baseline to 10 minutes

title

Appropriate Intraoperative Parathyroid Hormone Drop

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice