Clinical Validation of Probe-based Parathyroid Autofluorescence Detection System PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial

What this Trial Is About

Researchers are evaluating whether using a near-infrared autofluorescence (NIRAF) probe-based imaging system called PTeye can improve the identification and preservation of parathyroid glands during thyroid surgery compared to the surgeon's naked eye alone. This randomized clinical trial aims to determine if PTeye leads to better intraoperative detection of parathyroid glands and reduces the risk of postoperative complications like hypoparathyroidism. The study includes patients undergoing their first total thyroidectomy. Participants will be randomly assigned to one of two groups: thyroid surgery with PTeye or surgery using only visual identification by the surgeon. In the PTeye group, the surgeon will use a sterile fiber optic probe connected to the device to detect parathyroid tissue during surgery, with measurements recorded. In the control group, surgeons will identify glands by sight alone. Both groups will follow standard surgical protocols, including reimplantation of inadvertently removed glands when discovered. Throughout the study, data will be collected on surgery duration, frozen section analyses, blood calcium and parathyroid hormone levels before and after surgery, use of calcium and vitamin D supplements, and any complications or hospital visits. Researchers will compare these outcomes between groups to assess the value of PTeye. The primary measure is the number of parathyroid glands identified during surgery. Participants will be followed for up to six months postoperatively to monitor outcomes and safety.

PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial.