PTeye in Parathyroid Adenoma

Recruiting

• Conditions: Parathyroid Adenoma

• Registration Number: NCT06913296
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

Identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. Near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. The aim of the present study is to evaluate the correlation of PTeye autofluorescence device with biochemical data of parathyroid adenoma patients.

Detailed Description

Identifying the parathyroids is compulsory for success of parathyroidectomy for parathyroid adenoma. Near-infrared autofluorescence devices have been proposed as useful intraoperative tools for the identification of parathyroid glands. Two approaches are available to surgeons to perform near-infrared autofluorescence: (i) Camera-based systems (CBS) and (ii) Probe-based systems such as PTeye™ (Medtronic, Minneapolis, MN).The aim of the present study is to evaluate the correlation of PTeye autofluorescence device with biochemical data of parathyroid adenoma patients.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-28
• Study First Submitted: 2025-03-30
• Study First Submitted QC: 2025-03-30
• Last Update Submitted: 2025-03-30
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age >18 years old
• primary hyperparathyroidism caused by adenoma
• patient's informed consent acquired

Exclusion Criteria

• Secondary and tertiary hyperparathyroidism
• Re-operation for adenoma
• Previous neck surgery
• Patient enrolled in another study that may affect the results of this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assess the correlation of PTeye values with biochemical data	intraoperatively and 1st postoperative day	Biochemical data included are pre- and postoperative parathyroid hormone, serum calcium, phosphorus and vitamin D levels

Trial Locations

Locations (1)

Aristotle Univeristy of Thessaloniki; 🇬🇷 Thessaloniki, Greece