NCT05022641 · BASELINE

Baseline characteristics

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.

denoms

counts
group Id
BG000
value
81
group Id
BG001
value
79
group Id
BG002
value
160
units
Participants

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
BG000
title
PTeye
description
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
id
BG001
title
Standard of Care
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
15.2
value
61.3
group Id
BG001
spread
15.5
value
61.1
group Id
BG002
spread
15.3
value
61.2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
59
group Id
BG001
value
65
group Id
BG002
value
124
title
Female
measurements
group Id
BG000
value
22
group Id
BG001
value
14
group Id
BG002
value
36
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Hispanic or Latino
measurements
group Id
BG000
value
81
group Id
BG001
value
78
group Id
BG002
value
159
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
69
group Id
BG002
value
145
title
White
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Black
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
title
Asian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Other
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
79
group Id
BG002
value
160
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
78
group Id
BG001
value
77
group Id
BG002
value
155
title
Primary sporadic hyperparathyroidism
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
Recurrent/persistent hyperparathyroidism
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Other
description
Diagnosis was determined after undergoing procedure.
param Type
COUNT_OF_PARTICIPANTS
title
Final Diagnosis
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
78
value
125.9
group Id
BG001
spread
66.4
value
124.1
group Id
BG002
spread
72.3
value
125
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Preoperative PTH (pg/mL)
unit Of Measure
pg/mL
classes
categories
measurements
group Id
BG000
spread
4.4
value
11.5
group Id
BG001
spread
0.6
value
10.8
group Id
BG002
spread
3.2
value
11.2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Preoperative calcium (pg/dL)
unit Of Measure
pg/dL
classes
categories
measurements
group Id
BG000
spread
16
value
37.7
group Id
BG001
spread
15.2
value
35.8
group Id
BG002
spread
15.6
value
36.8
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Preoperative vitamin D (mcg)
unit Of Measure
mcg

Complete source fields

denoms

counts
group Id
BG000
value
81
group Id
BG001
value
79
group Id
BG002
value
160
units
Participants

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
BG000
title
PTeye
description
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
id
BG001
title
Standard of Care
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
15.2
value
61.3
group Id
BG001
spread
15.5
value
61.1
group Id
BG002
spread
15.3
value
61.2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
59
group Id
BG001
value
65
group Id
BG002
value
124
title
Female
measurements
group Id
BG000
value
22
group Id
BG001
value
14
group Id
BG002
value
36
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Hispanic or Latino
measurements
group Id
BG000
value
81
group Id
BG001
value
78
group Id
BG002
value
159
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
69
group Id
BG002
value
145
title
White
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Black
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
title
Asian
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Other
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
79
group Id
BG002
value
160
title
United States
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
78
group Id
BG001
value
77
group Id
BG002
value
155
title
Primary sporadic hyperparathyroidism
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
Recurrent/persistent hyperparathyroidism
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Other
description
Diagnosis was determined after undergoing procedure.
param Type
COUNT_OF_PARTICIPANTS
title
Final Diagnosis
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
78
value
125.9
group Id
BG001
spread
66.4
value
124.1
group Id
BG002
spread
72.3
value
125
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Preoperative PTH (pg/mL)
unit Of Measure
pg/mL
classes
categories
measurements
group Id
BG000
spread
4.4
value
11.5
group Id
BG001
spread
0.6
value
10.8
group Id
BG002
spread
3.2
value
11.2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Preoperative calcium (pg/dL)
unit Of Measure
pg/dL
classes
categories
measurements
group Id
BG000
spread
16
value
37.7
group Id
BG001
spread
15.2
value
35.8
group Id
BG002
spread
15.6
value
36.8
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Preoperative vitamin D (mcg)
unit Of Measure
mcg

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Preserved source evidence · Not medical advice