The goal of this observational study is to evaluate the efficacy of PTeyeTM device to confirm a parathyroid adenoma on a visually suspected tissue in comparison with the FLUOBEAM®LX device. The main questions it aims to answer is: Is the PTeyeTM device effective in identifying the presence of a parathyroid adenoma? Which autofluorecence device (PTeye or FLUOBEAM®LX) is more effective in confirming the presence of a parathyroid adenoma? Participants will undergo parathyroidectomy under general anesthesia. During the procedure visually suspected tissue for parathyroid adenoma will be evaluated with the PTeye or FLUOBEAM®LX device for the presence of an adenoma (minute 0). Tissue will be reevaluated on minutes 1, 3, and 5 and before excision.
Objective: PTeye™ and FLUOBEAM® LX use autofluorescence to confirm visually suspected parathyroid tissue. Real-time intraoperative identification of parathyroid glands can be achieved by the application of both devices. The aim of the present study is to evaluate and compare the efficacy of PTeye™ and FLUOBEAM® LX in identifying parathyroid adenomas. Methods: Patients undergoing parathyroidectomy due to a parathyroid adenoma will be enrolled prospectively in this study and will be randomly included to Group A (PTeye™) or Group B (FLUOBEAM® LX). After intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0), the efficacy of both devices to confirm the adenomas will be evaluated. Re-evaluation will take place in minutes 1, 3 and 5 during tissue dissection and before adenoma excision.
Study Type
OBSERVATIONAL
Enrollment
40
Parathyroidectomy under general anesthesia
Aristotle University of Thessaloniki
Thessaloniki, Greece
Identification of the parathyroid adenoma
The percentage of adenomas identified by each device is assessed after intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0). The same percentage will be re-evaluated on minutes 1, 3 and 5 during tissue dissection and before adenoma excision.
Time frame: The minute of the identification of the parathyroid adenoma (minute 0). Reevaluation in minutes 1, 3, and 5 during tissue dissection and before excision.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.