An interventional study of PTeye and Standard of Care in Parathyroid Adenoma, Parathyroid Neoplasms and Parathyroid Cancer, 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 2025-08-27.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.
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.
63 studies on the registry are indexed under Parathyroid Neoplasms; 19 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 38 interventional studies indexed under Parathyroid Neoplasms.
Browse Parathyroid Neoplasms studies →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.
Counted across the registry records on this site, refreshed daily.
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 parathyroid surgery.
Device: PTeye
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Other: Standard of Care
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 (see Figure 1), as per device functionality requirements.
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Average Number of Parathyroid Glands Identified
Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
Time frame: Measured within the procedure, generally not more than 2 hours
Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery
Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.
Time frame: 5-14 days after surgery
Appropriate Intraoperative Parathyroid Hormone Drop
\>50% drop from baseline at 10 minutes post-resection
Time frame: baseline to 10 minutes
Duration of Surgery
Surgery duration in minutes
Time frame: Measured within the procedure, generally not more than 2 hours
Number of Nights Spent in the Hospital After Parathyroidectomy
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Time frame: 0-72 hours after PTx procedure.
Number of Frozen Sections
Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.
Time frame: Immediate
| Milestone | PTeye | Standard of Care |
|---|---|---|
| Started | 81 | 79 |
| Completed | 81 | 79 |
| Not completed | 0 | 0 |
Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
| parathyroid glands per patient | PTeye | Standard of Care |
|---|---|---|
| Average Number of Parathyroid Glands Identified | 2.7 (2.4 to 2.9) | 2.6 (2.3 to 2.8) |
Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.
| pg/mL | PTeye | Standard of Care |
|---|---|---|
| Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery | 23 ± 26.9 | 25.3 ± 23.4 |
\>50% drop from baseline at 10 minutes post-resection
| Participants | PTeye | Standard of Care |
|---|---|---|
| Yes | 45 | 56 |
| No | 35 | 19 |
Surgery duration in minutes
| minutes | PTeye | Standard of Care |
|---|---|---|
| Duration of Surgery | 92.3 ± 40.2 | 88.8 ± 42.3 |
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
| Participants | PTeye | Standard of Care |
|---|---|---|
| 0 nights | 77 | 76 |
| 1 night | 4 | 3 |
Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.
| Participants | PTeye | Standard of Care |
|---|---|---|
| 0 frozen sections taken | 49 | 47 |
| 1 or more frozen sections taken | 32 | 32 |
Collected over Up to 6-months after surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PTeye | 0/81 (0%) | 0/81 (0%) | 0/81 (0%) |
| Standard of Care | 0/79 (0%) | 0/79 (0%) | 0/79 (0%) |
| Age, Continuous(years) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Mean | 61.3 ± 15.2 | 61.1 ± 15.5 | 61.2 ± 15.3 |
| Sex: Female, Male(Participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Female | 59 | 65 | 124 |
| Male | 22 | 14 | 36 |
| Ethnicity (NIH/OMB)(Participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 81 | 78 | 159 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| White | 76 | 69 | 145 |
| Black | 3 | 6 | 9 |
| Asian | 1 | 3 | 4 |
| Other | 1 | 1 | 2 |
| Region of Enrollment(participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| United States | 81 | 79 | 160 |
| Final Diagnosis(Participants) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Primary sporadic hyperparathyroidism | 78 | 77 | 155 |
| Recurrent/persistent hyperparathyroidism | 3 | 0 | 3 |
| Other | 0 | 2 | 2 |
| Preoperative PTH (pg/mL)(pg/mL) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Mean | 125.9 ± 78 | 124.1 ± 66.4 | 125 ± 72.3 |
| Preoperative calcium (pg/dL)(pg/dL) | PTeye | Standard of Care | Total |
|---|---|---|---|
| Mean | 11.5 ± 4.4 | 10.8 ± 0.6 | 11.2 ± 3.2 |
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.
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