Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study
NCT ID: NCT06788223
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
40 participants
OBSERVATIONAL
2024-11-01
2025-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PTeye
Localizing Parathyroid adenoma with the PTeye device during parathyroidectomy
Parathyroidectomy
Parathyroidectomy under general anesthesia
Fluobeam
Localizing Parathyroid adenoma with the Fluobeam/ Fluoptics device
Parathyroidectomy
Parathyroidectomy under general anesthesia
Interventions
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Parathyroidectomy
Parathyroidectomy under general anesthesia
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Secondary hyperparathyroidism
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Papavramidis Theodossis
Professor
Locations
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Aristotle University of Thessaloniki
Thessaloniki, , Greece
Countries
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Other Identifiers
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PTeye
Identifier Type: -
Identifier Source: org_study_id
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