Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Vanderbilt University | OTHER |
Not provided
Not provided
Not provided
This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Inadvertent damage or excision of a healthy parathyroid gland (PG) following a total thyroidectomy (TTx) could result in transient hypocalcemia (< 6 months) in 5 - 35% of cases or permanent hypocalcemia (> 6 months) in 7% of the patients (1, 2). In both of these circumstances, patients would require calcium and active vitamin D supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. These complications could be minimized with label-free intraoperative PG identification using near infrared autofluorescence (NIRAF) detection with a fiber-probe based approach as utilized in 'PTeye', which is medical device that was recently FDA-cleared. However, the true impact of this particular NIRAF-based approach on patient outcomes is yet to be determined
The aim of this prospective single blinded randomized study is to compare 2 groups of patients: TTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during TTx procedures with regard to postoperative hypocalcemia, PG identification, PG auto-transplantation and inadvertent resection rates compared to standard of care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIRAF Detection Technology (+) | Experimental | 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 (-) | No Intervention | Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRAF Detection Technology | Device | 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. Other Name: PTeye Device |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Transient Hypoparathyroidism. | The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level <10 pg/mL. | 24-48 hours post-op |
| Patients With Hypoparathyroidism at Last Follow-up | The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range. | 2 days to 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Average Number of Parathyroid Glands Identified With High Confidence. | Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) | Immediate (during total thyroidectomy, up to 3 hours) |
| Number of Participants With Frozen Sections Sent for Analysis. |
Not provided
Inclusion Criteria:
(i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).
(ii) All patients undergoing completion thyroidectomy.
Exclusion Criteria:
(i) Patients with concurrent parathyroid disease.
(ii) Patients with incidental enlarged parathyroid discovered during TTx.
(iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tracy S Wang, MD, MPH | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40668552 | Derived | Cousart AG, Kiernan CM, Willmon PA, Thomas G, Wang TS, Gauger PG, Duh QY, Underwood HJ, Jackson A, Patel A, Mahadevan-Jansen A, Solorzano CC. Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):936-944. doi: 10.1001/jamasurg.2025.2233. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Other Name: PTeye Device |
| FG001 | NIRAF Detection Technology (-) | Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Other Name: PTeye Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects With Transient Hypoparathyroidism. | The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level <10 pg/mL. | Posted | Count of Participants | Participants | 24-48 hours post-op |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Other Name: PTeye Device |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy Wang, MD | Medical College of Wisconsin | 414-955-1459 | tswang@mcw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2021 | Jun 10, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2023 | Apr 2, 2025 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND) in the interventional group.
Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology).
The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nanometer (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 Milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).
Not provided
Not provided
Only participants will be masked to the intervention.
|
Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue. |
| Immediate (during total thyroidectomy, up to 3 hours) |
| Number of Participants With Auto-transplanted Parathyroid Glands | Number of participants with auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized. | Immediate (during total thyroidectomy, up to 3 hours) |
| Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | Number of participants who spent nights for postoperative recovery in the hospital after the surgical procedure. | 0-72 hours after total thyroidectomy |
| Number of Participants With Inadvertently Resected Parathyroid Glands | Number of participants with inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. | Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report) |
| Number of Doctor Visits/Emergency Department Visits or Hospital Admissions | Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms. | Up to 6 months after total thyroidectomy |
| Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery | Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation. | Up to 6 months after total thyroidectomy |
| BG001 | NIRAF Detection Technology (-) | Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | NIRAF Detection Technology (-) | Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). |
|
|
| Primary | Patients With Hypoparathyroidism at Last Follow-up | The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range. | Posted | Count of Participants | Participants | 2 days to 1 year after surgery |
|
|
|
| Secondary | Overall Average Number of Parathyroid Glands Identified With High Confidence. | Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) | Posted | Mean | 95% Confidence Interval | Number of parathyroid glands | Immediate (during total thyroidectomy, up to 3 hours) |
|
|
|
| Secondary | Number of Participants With Frozen Sections Sent for Analysis. | Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue. | Posted | Count of Participants | Participants | Immediate (during total thyroidectomy, up to 3 hours) |
|
|
|
| Secondary | Number of Participants With Auto-transplanted Parathyroid Glands | Number of participants with auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized. | Posted | Count of Participants | Participants | Immediate (during total thyroidectomy, up to 3 hours) |
|
|
|
| Secondary | Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | Number of participants who spent nights for postoperative recovery in the hospital after the surgical procedure. | Posted | Count of Participants | Participants | 0-72 hours after total thyroidectomy |
|
|
|
| Secondary | Number of Participants With Inadvertently Resected Parathyroid Glands | Number of participants with inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. | Posted | Count of Participants | Participants | Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report) |
|
|
|
| Secondary | Number of Doctor Visits/Emergency Department Visits or Hospital Admissions | Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms. | Posted | Number | Number of events | Up to 6 months after total thyroidectomy |
|
|
|
| Secondary | Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery | Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation. | We would not be able to provide precise data regarding duration and total daily dosage. Following surgery, those at risk for hypocalcemia are prescribed calcium standing dose and patients are also counseled to take additional calcium supplements. It is not possible to calculate an exact dose. Patients often take calcium supplements. Therefore, the additional calcium and the exact duration of when they stopped additional calcium is challenging for patients and was not collected in the trial. | Posted | Up to 6 months after total thyroidectomy |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | NIRAF Detection Technology (-) | Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). | 0 | 41 | 0 | 41 | 0 | 41 |
Not provided
Not provided
Not provided
| D006258 |
| Head and Neck Neoplasms |
| greater than or equal to 2 auto-transplanted parathyroid glands |
|
| more than one night |
|