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
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.
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.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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University of Michigan