Trial Outcomes & Findings for Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy (NCT NCT04299425)
NCT ID: NCT04299425
Last Updated: 2024-05-13
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 PTx procedure.
Results posted on
2024-05-13
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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
|---|---|---|
|
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
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy
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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
79 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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)
|
30.77 kg/m2
STANDARD_DEVIATION 7.52 • n=5 Participants
|
30.94 kg/m2
STANDARD_DEVIATION 7.72 • n=7 Participants
|
30.85 kg/m2
STANDARD_DEVIATION 7.59 • n=5 Participants
|
|
Diagnosis
Primary sporadic HPT
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Diagnosis
Persistent HPT
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Diagnosis
Recurrent HPT
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diagnosis
MEN1
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diagnosis
Parathyroid carcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diagnosis
Lithium-induced HPT
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Preoperative calcium (pg/dL)
|
11.115 mg/dL
STANDARD_DEVIATION 0.689 • n=5 Participants
|
11.112 mg/dL
STANDARD_DEVIATION 0.712 • n=7 Participants
|
11.112 mg/dL
STANDARD_DEVIATION 0.712 • n=5 Participants
|
|
Preoperative PTH (pg/mL)
|
152.3 pg/mL
STANDARD_DEVIATION 79.8 • n=5 Participants
|
163.6 pg/mL
STANDARD_DEVIATION 139 • n=7 Participants
|
157.9 pg/mL
STANDARD_DEVIATION 112.7 • n=5 Participants
|
|
Preoperative vitamin D
|
36.7 mcg
STANDARD_DEVIATION 16 • n=5 Participants
|
39.6 mcg
STANDARD_DEVIATION 20.5 • n=7 Participants
|
38.1 mcg
STANDARD_DEVIATION 18.2 • n=5 Participants
|
|
Procedure by intention
Focused
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Procedure by intention
Bilateral
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediate. During PTx 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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
|---|---|---|
|
Average Number of Parathyroid Glands Identified With High Confidence Per Patient
|
3.1 parathyroid glands
Standard Deviation 1.21
|
2.7 parathyroid glands
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 6 months after PTx procedureIf blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month.
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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
|---|---|---|
|
Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediate. During PTx 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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
|---|---|---|
|
Number of Frozen Sections Sent for Analysis
|
13 frozen sections
|
45 frozen sections
|
SECONDARY outcome
Timeframe: Immediate. During PTx procedure.Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the 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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
|---|---|---|
|
Duration of Parathyroidectomy (PTx) Procedure
|
89.3 minutes
Standard Deviation 32.6
|
95.5 minutes
Standard Deviation 39.7
|
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 |
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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
|---|---|---|
|
Number of Participants Stratified by Duration of Hospital Stay
Discharged same day
|
64 Participants
|
66 Participants
|
|
Number of Participants Stratified by Duration of Hospital Stay
Overnight
|
14 Participants
|
14 Participants
|
|
Number of Participants Stratified by Duration of Hospital Stay
Admitted > 23 hours
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediate to 10 days after PTx procedure.Population: Only the NIRAF Detection Technology + arm was included in the analysis to calculate the rate of false positives by the device. Since the NIRAF Detection Technology - did not use the device that arm was not included.
Number of tissues that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology
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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
|---|---|---|
|
Number of 'False Positive' Tissues Excised by Surgeon
|
19 false positives
|
—
|
SECONDARY outcome
Timeframe: At 6-months post-operationPopulation: Nearly all patients attended their first follow-up appointment (5-14 days post-operation), however about 30 patients were lost for long-term follow-up.
Number of patients with repeat PTx procedure performed after the current procedure.
Outcome measures
| Measure |
NIRAF Detection Technology +
n=51 Participants
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
|
|---|---|---|
|
Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure
|
0 Participants
|
1 Participants
|
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