An observational study in Primary Hyperparathyroidism Due to Adenoma, sponsored by Aristotle University Of Thessaloniki. Active, not recruiting at 1 site in Greece. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Aristotle University Of Thessaloniki · Observational
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.
63 studies on the registry are indexed under Parathyroid Neoplasms; 19 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 20 observational studies indexed under Parathyroid Neoplasms.
Browse Parathyroid Neoplasms studies →Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.
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Patients with primary hyperparathyroidism and parathyroid adenoma, fulfilling the AAES guidelines indications for parathyroidectomy.
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Exclusion Criteria:
Localizing Parathyroid adenoma with the PTeye device during parathyroidectomy
Device: Parathyroidectomy
Localizing Parathyroid adenoma with the Fluobeam/ Fluoptics device
Device: Parathyroidectomy
Parathyroidectomy under general anesthesia
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.
Plan to share: Yes — Upon request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Jan 2025, 2 months after the start.
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This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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