{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"1.0","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"80"}],"units":"Participants"}],"description":"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.","groups":[{"description":"Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).\n\nNIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).\n\nAfter surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \\> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.","id":"OG000","title":"NIRAF Detection Technology +"},{"description":"Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).","id":"OG001","title":"NIRAF Detection Technology -"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"6 months after PTx procedure","title":"Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).","type":"SECONDARY","unitOfMeasure":"Participants"}