| Primary | 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) | | Posted | | Mean | 95% Confidence Interval | parathyroid glands per patient | | Immediate (During total thyroidectomy procedure) | | | | ID | Title | Description |
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| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0003.1(2.8 to 3.3)
- OG0012.9(2.6 to 3.2)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | t-test, 2 sided | | 0.3 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery | Blood parathyroid hormone (PTH) levels at 5-14 days post-op | Not all participants returned for this lab assessment during the 5-14 day data collection period. As such, no data for these participants was collected. | Posted | | Mean | Standard Deviation | pg/mL | | 5-14 days after surgery | | | | ID | Title | Description |
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| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
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| Secondary | Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery | Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery | Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected. | Posted | | Mean | Standard Deviation | pg/mL | | Within 24-48 hours after surgery | | | | ID | Title | Description |
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| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
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| Secondary | Blood Calcium Levels 24-48 Hours After Surgery | Blood calcium levels 24-48 hours after surgery | Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected. | Posted | | Mean | Standard Deviation | pg/dL | | Within 24-48 hours after surgery | | | | ID | Title | Description |
|---|
| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
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| Secondary | Duration in Minutes of Surgery | Duration of surgery (minutes) | | Posted | | Mean | Standard Deviation | minutes | | Collected immediately following surgery | | | | ID | Title | Description |
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| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | Collected immediately following surgery | | | | ID | Title | Description |
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| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
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| Secondary | Number of Auto-transplanted Parathyroid Glands | Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized. | | Posted | | Count of Participants | | Participants | | Immediate. During total thyroidectomy procedure | | | | ID | Title | Description |
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| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
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| Secondary | Number of Nights Spent in the Hospital After Total Thyroidectomy | Number of nights spent for postoperative recovery in the hospital after the surgical procedure. | | Posted | | Count of Participants | | Participants | | 0 - 4 nights after total thyroidectomy | | | | ID | Title | Description |
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| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report) | | | | ID | Title | Description |
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| OG000 | PTeye | 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. PTeye: 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. | | OG001 | Standard of Care | 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. |
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