Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue

Time frame: At the end of the parathyroidectomy, up to 5 hours

Median time in minutes taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops \> 50% of its baseline value and/or PTH drops \< 65 pg/ml or 6.9 pmol/L

Time frame: At the end of the parathyroidectomy, up to 5 hours

Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes

Time frame: Up to 5 hours

Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG

Time frame: During parathyroidectomy, up to 5 hours

Population: Data was not collected for one participant from each group

Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG

Time frame: At the end of the parathyroidectomy, up to 5 hours

Population: Data was not collected for one participant from each group

Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound

Time frame: At the end of the parathyroidectomy, up to 5 hours

The median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology

Time frame: Up to 10 days after PTx procedure

The median number of intra-operative parathyroid hormone assays (per person) sent during the procedure to the lab

Time frame: At the end of the parathyroidectomy, up to 5 hours

Median number of nights spent in the hospital post-surgery is defined as having spent \<= 23 hours (0 nights) or \> 23 hours (1 night) at the hospital for postoperative recovery after the surgical procedure. Participants who had surgery scheduled for later in the day will be counted as spending one night in the hospital due to the minimum required observation period post-surgery and followed institutional standards for discharge; discharged the next day. Participants who had surgery scheduled for earlier in the day were discharged on the same day of surgery.

Time frame: 0-72 hours after PTx procedure

Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)

Time frame: At the end of the parathyroidectomy, up to 5 hours

Population: Only 4 participants had glands identified with NIRAF, which was not seen with surgeon's naked eye

Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)

Time frame: At the end of the parathyroidectomy, up to 5 hours

If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.

Time frame: Up to 6 months after PTx procedure

Population: Participants from both groups were missing labs. Not all PTEye participants returned to the clinic for blood draws within 5-14 days to obtain lab values required to calculate this endpoint and standard clinical care does not necessitate participants returning for labs routinely at each follow-up time points.

Number of participants with an indication that repeat PTx procedure may need to be performed after the current procedure will be categorized as binary (yes or no)

Time frame: From 6 - 12 months after PTx procedure

Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop \> 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop \< 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.

Time frame: 5-14 days after PTx procedure

Elevated blood calcium levels (total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH \> 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.

Time frame: 5-14 days after PTx procedure

Population: Participants from both groups were missing labs. Not all PTEye participants returned to the clinic for blood draws within 5-14 days to obtain lab values required to calculate this endpoint and standard clinical care does not necessitate participants returning for labs routinely at each follow-up time points.

Number of participants who required a doctor visit/emergency department visit and/or hospital admission due to persistent hypercalcemia and/or associated symptoms after the parathyroidectomy procedure will be categorized as binary (yes or no) if any follow-up visits or admissions occurred.

Time frame: Up to 6 months after PTx procedure