An interventional study of PTeye in Thyroid Neoplasms, Thyroid Diseases and Hypoparathyroidism, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
Among 283 studies in Thyroid Neoplasms with a site in United States — 55 open to participants now, 91 under way, 3 of them phase 3. Thyroid Neoplasms · United States.
Among the 283 studies in Thyroid Neoplasms with a site in United States, this one is the 44th largest by enrollment of the 231 interventional ones, is one of 16 that started in 2021, is one of 50 with no phase, and was the 232nd registered.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's enrollment of 114 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →55 of the 283 studies in Thyroid Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 152 Thyroid Neoplasms studies recruiting now, 96 (63%) set no upper age limit and 27 (18%) stop at 75 or younger; 37 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →283 studies; the count open now beside each. This study's row is marked.
First in 1977; this study’s year is marked. 16 started in 2021.
Median enrollment 34 across the 231 interventional studies, 200 across the 47 observational. Of the 180 that completed or were terminated, 93 (52%) have results posted.
69 of 283 have an industry lead sponsor. The 10 most frequent:
University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
University of Michigan has 2 studies filed under Thyroid Neoplasms — fewer than ten, so there is no comparison to draw.
27 of the studies in Thyroid Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07023731Arvinas Inc.A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation | 2026-11-30 |
| NCT03099356University of Michigan Rogel Cancer CenterCyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer | 2026-12 |
| NCT06220656Dartmouth-Hitchcock Medical CenterTRAIL Study: Feasibility and Pilot | 2026-12 |
| NCT05366881Adela, InccfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease | 2026-12-31 |
| NCT06207188Mayo ClinicIdentification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters | 2026-12-31 |
Among the 283 studies in Thyroid Neoplasms with a site in United States, from their registry updates:
This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: PTeye
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 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.
The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
Time frame: Immediate (During total thyroidectomy procedure)
Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery
Blood parathyroid hormone (PTH) levels at 5-14 days post-op
Time frame: 5-14 days after surgery
Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery
Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery
Time frame: Within 24-48 hours after surgery
Blood Calcium Levels 24-48 Hours After Surgery
Blood calcium levels 24-48 hours after surgery
Time frame: Within 24-48 hours after surgery
Duration in Minutes of Surgery
Duration of surgery (minutes)
Time frame: Collected immediately following surgery
Number of Frozen Section Analysis Performed.
Number 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.
Time frame: Collected immediately following surgery
Number of Auto-transplanted Parathyroid Glands
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Time frame: Immediate. During total thyroidectomy procedure
Number of Nights Spent in the Hospital After Total Thyroidectomy
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Time frame: 0 - 4 nights after total thyroidectomy
Number of Inadvertently Resected Parathyroid Glands
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.
Time frame: Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)
| Milestone | PTeye | Standard of Care |
|---|---|---|
| Started | 57 | 57 |
| Completed | 57 | 57 |
| Not completed | 0 | 0 |
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
| parathyroid glands per patient | PTeye | Standard of Care |
|---|---|---|
| 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 (2.8 to 3.3) | 2.9 (2.6 to 3.2) |
Blood parathyroid hormone (PTH) levels at 5-14 days post-op
| pg/mL | PTeye | Standard of Care |
|---|---|---|
| Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery | 35.6 ± 25.3 | 41 ± 34.7 |
Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery
| pg/mL | PTeye | Standard of Care |
|---|---|---|
| Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery | 20.7 ± 11.6 | 24.3 ± 16.6 |
Blood calcium levels 24-48 hours after surgery
| pg/dL | PTeye | Standard of Care |
|---|---|---|
| Blood Calcium Levels 24-48 Hours After Surgery | 9.4 ± .5 | 9.3 ± .5 |
Duration of surgery (minutes)
| minutes | PTeye | Standard of Care |
|---|---|---|
| Duration in Minutes of Surgery | 126.2 ± 39.6 | 120.3 ± 34.7 |
Number 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.
| Participants | PTeye | Standard of Care |
|---|---|---|
| 0 | 55 | 55 |
| 1 or more | 2 | 2 |
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
| Participants | PTeye | Standard of Care |
|---|---|---|
| 0 | 41 | 46 |
| 1 | 16 | 10 |
| 2 or more | 0 | 1 |
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
| Participants | PTeye | Standard of Care |
|---|---|---|
| 0 nights | 0 | 0 |
| 1 night | 57 | 57 |
| > 1 night | 0 | 0 |
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.
| Participants | PTeye | Standard of Care |
|---|---|---|
| Number of Inadvertently Resected Parathyroid Glands | 5 | 5 |
Collected over Adverse event data was collected up to 6-months after surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PTeye | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Standard of Care | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Age, Continuous(years) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Mean | 51.2 ± 16.9 | 52.6 ± 16 | 51.9 ± 16.4 |
| Sex: Female, Male(Participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Female | 44 | 43 | 87 |
| Male | 13 | 14 | 27 |
| Ethnicity (NIH/OMB)(Participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 54 | 55 | 109 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| White | 47 | 49 | 96 |
| Black | 4 | 3 | 7 |
| Asian | 3 | 4 | 7 |
| Other | 3 | 1 | 4 |
| Region of Enrollment(Participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| United States | 57 | 57 | 114 |
| Preoperative calcium (pg/dL)((pg/dL)) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Mean | 9.4 ± 0.5 | 9.5 ± 0.4 | 9.5 ± 0.5 |
| Preoperative PTH (pg/mL)((pg/mL)) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Mean | 48.2 ± 22.4 | 78.3 ± 25 | 64.6 ± 27.9 |
| Preoperative vitamin D (mcg)(mcg) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Mean | 33 ± 13.6 | 29.3 ± 11 | 30.9 ± 12 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2021 to primary completion in May 2024, 29 months.
Results were first posted in Aug 2025, 1 year 2 months after primary completion. A results delay was requested in May 2025.
Of 126 non-industry interventional studies with no phase under Thyroid Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 78. This study's 29 months is below that.
Counting every sponsor, half of 127 studies reached it within 46 months; a quarter within 14 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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