NCT05022667 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse event data was collected up to 6-months after surgery.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	0 / 57	0 / 57	0 / 57
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.	0 / 57	0 / 57	0 / 57

Group identifiers: EG000: PTeye · EG001: Standard of Care

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
57
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
EG000
other Num Affected
0
other Num At Risk
57
serious Num Affected
0
serious Num At Risk
57
title
PTeye
deaths Num Affected
0
deaths Num At Risk
57
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
EG001
other Num Affected
0
other Num At Risk
57
serious Num Affected
0
serious Num At Risk
57
title
Standard of Care

frequency Threshold

time Frame

Adverse event data was collected up to 6-months after surgery.

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

Preserved source evidence · Not medical advice