| Primary | Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis | Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue | | Posted | | Median | Full Range | frozen aspirate samples | | At the end of the parathyroidectomy, up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000(0 to 1)
- OG0010(0 to 1)
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| Secondary | Number of Participants With Persistent Hyperparathyroidism (Immediate) | 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. | | Posted | | Count of Participants | | Participants | | 5-14 days after PTx procedure | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient) | 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. | 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. | Posted | | Count of Participants | | Participants | | 5-14 days after PTx procedure | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy) | 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. | 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. | Posted | | Count of Participants | | Participants | | Up to 6 months after PTx procedure | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Number of Parathyroid Glands (PG) Identified | 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) | | Posted | | Number | | parathyroid glands | | At the end of the parathyroidectomy, up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only) | 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) | Only 4 participants had glands identified with NIRAF, which was not seen with surgeon's naked eye | Posted | | Median | Full Range | parathyroid glands | | At the end of the parathyroidectomy, up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. |
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| Secondary | Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands | Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound | | Posted | | Median | Full Range | parathyroid glands | | At the end of the parathyroidectomy, up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent | The median number of intra-operative parathyroid hormone assays (per person) sent during the procedure to the lab | | Posted | | Median | Full Range | assays | | At the end of the parathyroidectomy, up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Median Duration Taken to Identify First Parathyroid Gland | Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG | Data was not collected for one participant from each group | Posted | | Median | Inter-Quartile Range | minutes | | During parathyroidectomy, up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Median Duration Taken to Identify Last Parathyroid Gland | Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG | Data was not collected for one participant from each group | Posted | | Median | Inter-Quartile Range | minutes | | At the end of the parathyroidectomy, up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Median Duration of Parathyroidectomy (PTx) Procedure | Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes | | Posted | | Median | Inter-Quartile Range | minutes | | Up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize | 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 | | Posted | | Median | Inter-Quartile Range | minutes | | At the end of the parathyroidectomy, up to 5 hours | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Median Number of Nights in the Hospital After Parathyroidectomy | 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. | | Posted | | Median | Full Range | number of nights | | 0-72 hours after PTx procedure | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Median Number of 'False Positive' Tissue Samples Excised by Surgeon | 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 | | Posted | | Median | Full Range | tissue samples | | Up to 10 days after PTx procedure | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions | 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. | | Posted | | Number | | participants | | Up to 6 months after PTx procedure | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Secondary | Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure | 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) | | Posted | | Count of Participants | | Participants | | From 6 - 12 months after PTx procedure | | | | ID | Title | Description |
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| OG000 | Parathyroid Eye (PTeye) | For participants assigned to the study arm, 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. | | OG001 | Usual Standard of Care | The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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