NCT05152927 · OUTCOME

Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize

Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy · Source last updated 2025-12-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: minutes
Interval / dispersion: Inter-Quartile Range
Time frame: At the end of the parathyroidectomy, up to 5 hours

What was measured

Median time in minutes taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops \> 50% of its baseline value and/or PTH drops \< 65 pg/ml or 6.9 pmol/L

Groups in this outcome

Parathyroid Eye (PTeye)

For participants assigned to the study arm, 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.

Usual Standard of Care

The surgeon will proceed with the parathyroid surgery 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
Parathyroid Eye (PTeye)	38
Usual Standard of Care	41

Reported measurements

Source class 1

Values in minutes · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Parathyroid Eye (PTeye)	76	Not reported	27	243	Not reported
Usual Standard of Care	66	Not reported	38	150	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
27
upper Limit
243
value
76
group Id
OG001
lower Limit
38
upper Limit
150
value
66

denoms

counts
group Id
OG000
value
38
group Id
OG001
value
41
units
Participants

description

Median time in minutes taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops \> 50% of its baseline value and/or PTH drops \< 65 pg/ml or 6.9 pmol/L

dispersion Type

Inter-Quartile Range

groups

description
For participants assigned to the study arm, 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.
id
OG000
title
Parathyroid Eye (PTeye)
description
The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
id
OG001
title
Usual Standard of Care

param Type

MEDIAN

reporting Status

POSTED

time Frame

At the end of the parathyroidectomy, up to 5 hours

title

Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize

type

SECONDARY

unit Of Measure

minutes

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

Preserved source evidence · Not medical advice