Trial Outcomes & Findings for Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy (NCT NCT05022667)
NCT ID: NCT05022667
Last Updated: 2025-08-08
Results Overview
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
Immediate (During total thyroidectomy procedure)
Results posted on
2025-08-08
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 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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Baseline characteristics by cohort
| Measure |
PTeye
n=57 Participants
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.
|
Standard of Care
n=57 Participants
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.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 16.9 • n=99 Participants
|
52.6 years
STANDARD_DEVIATION 16 • n=107 Participants
|
51.9 years
STANDARD_DEVIATION 16.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Preoperative calcium (pg/dL)
|
9.4 (pg/dL)
STANDARD_DEVIATION 0.5 • n=99 Participants
|
9.5 (pg/dL)
STANDARD_DEVIATION 0.4 • n=107 Participants
|
9.5 (pg/dL)
STANDARD_DEVIATION 0.5 • n=206 Participants
|
|
Preoperative PTH (pg/mL)
|
48.2 (pg/mL)
STANDARD_DEVIATION 22.4 • n=99 Participants
|
78.3 (pg/mL)
STANDARD_DEVIATION 25 • n=107 Participants
|
64.6 (pg/mL)
STANDARD_DEVIATION 27.9 • n=206 Participants
|
|
Preoperative vitamin D (mcg)
|
33 mcg
STANDARD_DEVIATION 13.6 • n=99 Participants
|
29.3 mcg
STANDARD_DEVIATION 11 • n=107 Participants
|
30.9 mcg
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Final Diagnosis
Grave's disease
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Final Diagnosis
Goiters and nodular diseases
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Final Diagnosis
Thyroid cancer
|
26 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediate (During total thyroidectomy procedure)Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
Outcome measures
| Measure |
PTeye
n=57 Participants
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.
|
Standard of Care
n=57 Participants
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.
|
|---|---|---|
|
The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
|
3.1 parathyroid glands per patient
Interval 2.8 to 3.3
|
2.9 parathyroid glands per patient
Interval 2.6 to 3.2
|
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.
Blood parathyroid hormone (PTH) levels at 5-14 days post-op
Outcome measures
| Measure |
PTeye
n=35 Participants
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.
|
Standard of Care
n=36 Participants
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.
|
|---|---|---|
|
Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery
|
35.6 pg/mL
Standard Deviation 25.3
|
41 pg/mL
Standard Deviation 34.7
|
SECONDARY outcome
Timeframe: Within 24-48 hours after surgeryPopulation: Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected.
Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery
Outcome measures
| Measure |
PTeye
n=56 Participants
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.
|
Standard of Care
n=52 Participants
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.
|
|---|---|---|
|
Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery
|
20.7 pg/mL
Standard Deviation 11.6
|
24.3 pg/mL
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Within 24-48 hours after surgeryPopulation: Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected.
Blood calcium levels 24-48 hours after surgery
Outcome measures
| Measure |
PTeye
n=54 Participants
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.
|
Standard of Care
n=52 Participants
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.
|
|---|---|---|
|
Blood Calcium Levels 24-48 Hours After Surgery
|
9.4 pg/dL
Standard Deviation .5
|
9.3 pg/dL
Standard Deviation .5
|
SECONDARY outcome
Timeframe: Collected immediately following surgeryDuration of surgery (minutes)
Outcome measures
| Measure |
PTeye
n=57 Participants
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.
|
Standard of Care
n=57 Participants
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.
|
|---|---|---|
|
Duration in Minutes of Surgery
|
126.2 minutes
Standard Deviation 39.6
|
120.3 minutes
Standard Deviation 34.7
|
SECONDARY outcome
Timeframe: Collected immediately following surgeryNumber of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.
Outcome measures
| Measure |
PTeye
n=57 Participants
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.
|
Standard of Care
n=57 Participants
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.
|
|---|---|---|
|
Number of Frozen Section Analysis Performed.
0
|
55 Participants
|
55 Participants
|
|
Number of Frozen Section Analysis Performed.
1 or more
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediate. During total thyroidectomy procedureNumber of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Outcome measures
| Measure |
PTeye
n=57 Participants
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.
|
Standard of Care
n=57 Participants
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.
|
|---|---|---|
|
Number of Auto-transplanted Parathyroid Glands
0
|
41 Participants
|
46 Participants
|
|
Number of Auto-transplanted Parathyroid Glands
1
|
16 Participants
|
10 Participants
|
|
Number of Auto-transplanted Parathyroid Glands
2 or more
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0 - 4 nights after total thyroidectomyNumber of nights spent for postoperative recovery in the hospital after the surgical procedure.
Outcome measures
| Measure |
PTeye
n=57 Participants
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.
|
Standard of Care
n=57 Participants
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.
|
|---|---|---|
|
Number of Nights Spent in the Hospital After Total Thyroidectomy
0 nights
|
0 Participants
|
0 Participants
|
|
Number of Nights Spent in the Hospital After Total Thyroidectomy
1 night
|
57 Participants
|
57 Participants
|
|
Number of Nights Spent in the Hospital After Total Thyroidectomy
> 1 night
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. Results reflect the participants who had an inadvertently resected parathyroid gland.
Outcome measures
| Measure |
PTeye
n=57 Participants
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.
|
Standard of Care
n=57 Participants
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.
|
|---|---|---|
|
Number of Inadvertently Resected Parathyroid Glands
|
5 Participants
|
5 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