Trial Outcomes & Findings for Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy. (NCT NCT04281875)
NCT ID: NCT04281875
Last Updated: 2024-10-17
Results Overview
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
Immediate. During total thyroidectomy procedure.
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
NIRAF Detection Technology +
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
80
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy.
Baseline characteristics by cohort
| Measure |
NIRAF Detection Technology +
n=80 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=80 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
80 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.9 kg/m2
STANDARD_DEVIATION 8.8 • n=5 Participants
|
32.3 kg/m2
STANDARD_DEVIATION 8.4 • n=7 Participants
|
32.1 kg/m2
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Diagnosis
Graves' Diseases
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Diagnosis
Goiters and Nodular Diseases
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Diagnosis
Thyroid Cancers
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Preoperative calcium (pg/dL)
|
9.5 pg/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
9.4 pg/dL
STANDARD_DEVIATION 0.4 • n=7 Participants
|
9.5 pg/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Preoperative PTH (pg/mL)
|
62.6 pg/mL
STANDARD_DEVIATION 28 • n=5 Participants
|
81.1 pg/mL
STANDARD_DEVIATION 51.1 • n=7 Participants
|
71.3 pg/mL
STANDARD_DEVIATION 40 • n=5 Participants
|
|
Preoperative vitamin D (mcg)
|
29.5 mcg
STANDARD_DEVIATION 13 • n=5 Participants
|
34.6 mcg
STANDARD_DEVIATION 20.6 • n=7 Participants
|
32 mcg
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Procedure
Total Thyroidectomy
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Procedure
Total Thyroidectomy with Central Neck Dissection
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Procedure
Reoperation
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediate. During total thyroidectomy procedure.Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
Outcome measures
| Measure |
NIRAF Detection Technology +
n=80 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=80 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Average Number of Parathyroid Glands Identified With High Confidence Per Patient
|
2.81 parathyroid glands
Standard Deviation 1.03
|
2.75 parathyroid glands
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 6 months after total thyroidectomyPopulation: Only participants with at least 6-months of follow-up were included in this analysis. The majority of follow-ups for thyroid surgery occured nat 5-14 days post-operation and most people do not return for longer follow-up unless they have on-going abnormal labs after that mark.
If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level and/or PTH is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if PTH \< 16 pg/mL and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.
Outcome measures
| Measure |
NIRAF Detection Technology +
n=3 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=5 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 days to 6 months after total thyroidectomy.Population: Not all of the patients come back for follow-up.
Undetectable postoperative PTH and/or low calcium (total calcium \< 2mmol/L or 8 mg/dL, serum intact PTH \< 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-30 days after total thyroidectomy).
Outcome measures
| Measure |
NIRAF Detection Technology +
n=56 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=50 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Postoperative Hypoparathyroidism/Hypocalcemia (Transient)
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within 24 hours after total thyroidectomy.Population: 1 participant did not have their labs completed until 5-14 days post-operation.
Postoperative low calcium (total calcium \<8mg/dL or \<2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH \< 16 pg/mL or 1 pmol/L) within 24 hours after surgery
Outcome measures
| Measure |
NIRAF Detection Technology +
n=80 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=79 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Immediate. During total thyroidectomy procedure.Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Outcome measures
| Measure |
NIRAF Detection Technology +
n=80 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=80 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).
|
0.08 frozen sections
Standard Deviation 0.4
|
0.1 frozen sections
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Immediate. During total thyroidectomy procedure.Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Outcome measures
| Measure |
NIRAF Detection Technology +
n=80 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=80 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Number of Auto-transplanted Parathyroid Glands
|
43 parathyroid glands
|
39 parathyroid glands
|
SECONDARY outcome
Timeframe: 0 - 4 nights after total thyroidectomyNumber of nights spent in the hospital after the surgical procedure. 0 nights, 1 night, \>1 night
Outcome measures
| Measure |
NIRAF Detection Technology +
n=80 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=80 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Number of Nights Spent in the Hospital After Total Thyroidectomy
0 Nights
|
1 Participants
|
4 Participants
|
|
Number of Nights Spent in the Hospital After Total Thyroidectomy
1 Night
|
77 Participants
|
72 Participants
|
|
Number of Nights Spent in the Hospital After Total Thyroidectomy
> 1 Night
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Intraoperatively or on histology (within 24 hours post operation)Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
Outcome measures
| Measure |
NIRAF Detection Technology +
n=80 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
|
NIRAF Detection Technology -
n=80 Participants
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
|
|---|---|---|
|
Number of Inadvertently Resected Parathyroid Glands
|
0.09 parathyroid glands
Standard Deviation 0.3
|
0.06 parathyroid glands
Standard Deviation 0.2
|
Adverse Events
NIRAF Detection Technology +
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NIRAF Detection Technology -
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
Dr. Carmen C Solorzano
Vanderbilt University Medical Center
Phone: 615-343-2735
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place