Trial Outcomes & Findings for Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy (NCT NCT05022641)
NCT ID: NCT05022641
Last Updated: 2025-08-27
Results Overview
Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
Measured within the procedure, generally not more than 2 hours
Results posted on
2025-08-27
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
79
|
|
Overall Study
COMPLETED
|
81
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Baseline characteristics by cohort
| Measure |
PTeye
n=81 Participants
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
n=79 Participants
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 15.2 • n=93 Participants
|
61.1 years
STANDARD_DEVIATION 15.5 • n=4 Participants
|
61.2 years
STANDARD_DEVIATION 15.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
124 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
76 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
145 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=93 Participants
|
79 participants
n=4 Participants
|
160 participants
n=27 Participants
|
|
Final Diagnosis
Primary sporadic hyperparathyroidism
|
78 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
155 Participants
n=27 Participants
|
|
Final Diagnosis
Recurrent/persistent hyperparathyroidism
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Final Diagnosis
Other
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Preoperative PTH (pg/mL)
|
125.9 pg/mL
STANDARD_DEVIATION 78 • n=93 Participants
|
124.1 pg/mL
STANDARD_DEVIATION 66.4 • n=4 Participants
|
125 pg/mL
STANDARD_DEVIATION 72.3 • n=27 Participants
|
|
Preoperative calcium (pg/dL)
|
11.5 pg/dL
STANDARD_DEVIATION 4.4 • n=93 Participants
|
10.8 pg/dL
STANDARD_DEVIATION 0.6 • n=4 Participants
|
11.2 pg/dL
STANDARD_DEVIATION 3.2 • n=27 Participants
|
|
Preoperative vitamin D (mcg)
|
37.7 mcg
STANDARD_DEVIATION 16 • n=93 Participants
|
35.8 mcg
STANDARD_DEVIATION 15.2 • n=4 Participants
|
36.8 mcg
STANDARD_DEVIATION 15.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: Measured within the procedure, generally not more than 2 hoursAverage number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
Outcome measures
| Measure |
PTeye
n=81 Participants
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
n=79 Participants
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
|
|---|---|---|
|
Average Number of Parathyroid Glands Identified
|
2.7 parathyroid glands per patient
Interval 2.4 to 2.9
|
2.6 parathyroid glands per patient
Interval 2.3 to 2.8
|
SECONDARY outcome
Timeframe: 5-14 days after surgeryPopulation: Not all participants returned for this lab assessment during the 5-14 day data collection period. As such, no data for these participants was collected.
Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.
Outcome measures
| Measure |
PTeye
n=52 Participants
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
n=58 Participants
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery
|
23 pg/mL
Standard Deviation 26.9
|
25.3 pg/mL
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: baseline to 10 minutesPopulation: Some participants' data was not collected by the surgeons during the baseline-to-10-minute time frame.
\>50% drop from baseline at 10 minutes post-resection
Outcome measures
| Measure |
PTeye
n=80 Participants
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
n=75 Participants
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
|
|---|---|---|
|
Appropriate Intraoperative Parathyroid Hormone Drop
Yes
|
45 Participants
|
56 Participants
|
|
Appropriate Intraoperative Parathyroid Hormone Drop
No
|
35 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Measured within the procedure, generally not more than 2 hoursSurgery duration in minutes
Outcome measures
| Measure |
PTeye
n=81 Participants
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
n=79 Participants
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
|
|---|---|---|
|
Duration of Surgery
|
92.3 minutes
Standard Deviation 40.2
|
88.8 minutes
Standard Deviation 42.3
|
SECONDARY outcome
Timeframe: 0-72 hours after PTx procedure.Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Outcome measures
| Measure |
PTeye
n=81 Participants
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
n=79 Participants
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
|
|---|---|---|
|
Number of Nights Spent in the Hospital After Parathyroidectomy
0 nights
|
77 Participants
|
76 Participants
|
|
Number of Nights Spent in the Hospital After Parathyroidectomy
1 night
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: ImmediateTotal number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.
Outcome measures
| Measure |
PTeye
n=81 Participants
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
n=79 Participants
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
|
|---|---|---|
|
Number of Frozen Sections
0 frozen sections taken
|
49 Participants
|
47 Participants
|
|
Number of Frozen Sections
1 or more frozen sections taken
|
32 Participants
|
32 Participants
|
Adverse Events
PTeye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place