PTeye in Parathyroid Adenoma

NCT ID: NCT06913296

Last Updated: 2025-04-06

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-28

Study Completion Date

2025-05-30

Brief Summary

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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

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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.

Conditions

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Parathyroid Adenoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Parathyroid adenoma patients

Patients undergoing surgery for parathyroid adenoma will be enrolled in this study. Parathyroid glands will be identified with the application of autofluorescence device PTeye and the values obtained by the device after parathyroid gland recognition will be registered.

parathyroidectomy

Intervention Type PROCEDURE

typical open parathyroidectomy

Interventions

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parathyroidectomy

typical open parathyroidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Papavramidis Theodossis

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moysis Moysidis, Dr

Role: STUDY_CHAIR

Euromedica Kyanos Stavros

Chrysa Papadopoulou

Role: STUDY_CHAIR

Euromedica Kyanos Stavros

Locations

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Aristotle Univeristy of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Theodossis Papavramidis, Professor of Surgery

Role: CONTACT

+306944536972

Angeliki Chorti, Dr

Role: CONTACT

Facility Contacts

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Theodossis Papavramidis

Role: primary

+306944536972

Other Identifiers

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PTeye adenoma

Identifier Type: -

Identifier Source: org_study_id

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