Postoperative HypoparathyroidismNCT05579782
Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy
A study testing NIRAF Detection Technology in people with Postoperative Hypoparathyroidism and Thyroid Disease, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Hypoparathyroidism, Thyroid Disease, Thyroid Neoplasms
- What is being tested?
- NIRAF Detection Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- All patients undergoing completion thyroidectomy.
Who cannot join
- Patients with concurrent parathyroid disease.
- Patients with incidental enlarged parathyroid discovered during TTx.
- Patients undergoing thyroid lobectomy/partial thyroidectomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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.
Read the detailed description
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.
- Being tested
- NIRAF Detection Technology
- Medical subject headings
- Thyroid Diseases, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRAF Detection TechnologyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: NIRAF Detection Technology |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 days to 1 year after surgery
Secondary outcomes (7)
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)
Measured: Immediate (during total thyroidectomy, up to 3 hours)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months after total thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start5 Oct 2022
- Primary completion29 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Vanderbilt University
- Responsible party
- Principal investigator, Tracy S. Wang, Medical College of Wisconsin
- Investigators
- Tracy S Wang, MD, MPH, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579782
- Sponsor's protocol ID
- 00040573
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2022
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40668552
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT05579782
- Acronym / sponsor ID
- 00040573
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Vanderbilt University
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| NIRAF Detection Technology (+) | Experimental | Device: NIRAF Detection TechnologyParathyroid 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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
- All patients undergoing completion thyroidectomy.
Key exclusion criteria (3 listed)
- Patients with concurrent parathyroid disease.
- Patients with incidental enlarged parathyroid discovered during TTx.
- Patients undergoing thyroid lobectomy/partial thyroidectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRAF Detection TechnologyNear 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 | Device | NIRAF Detection Technology (+) |
Primary outcome
Subjects With Transient Hypoparathyroidism.
Time frame: 24-48 hours post-op
The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level <10 pg/mL.
Patients With Hypoparathyroidism at Last Follow-up
Time frame: 2 days to 1 year after surgery
The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range.
7 secondary outcomes
Overall Average Number of Parathyroid Glands Identified With High Confidence.
Time frame: Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants With Frozen Sections Sent for Analysis.
Time frame: Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants With Auto-transplanted Parathyroid Glands
Time frame: Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy
Time frame: 0-72 hours after total thyroidectomy
Number of Participants With Inadvertently Resected Parathyroid Glands
Time frame: Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report)
Number of Doctor Visits/Emergency Department Visits or Hospital Admissions
Time frame: Up to 6 months after total thyroidectomy
Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery
Time frame: Up to 6 months after total thyroidectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40668552Cousart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy S Wang, MD, MPH principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRAF Detection Technology in people with Postoperative Hypoparathyroidism and Thyroid Disease, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects With Transient Hypoparathyroidism. (time frame: 24-48 hours post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05579782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.