PTeye in Parathyroid Adenoma

March 30, 2025 updated by: Papavramidis Theodossis, Aristotle University Of Thessaloniki

Do PTeye Score Correlate With Biochemical Markers in Parathyroid Adenoma?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Thessaloniki, Greece, 54636
        • Recruiting
        • Aristotle Univeristy of Thessaloniki
        • Contact:
        • Contact:
          • Angeliki Chorti, Dr
        • Contact:
          • Moysis Moysidis, Dr
        • Contact:
          • Chrysa Papadopoulou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing surgery for parathyroid adenoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: parathyroidectomy
typical open parathyroidectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Study Chair: Moysis Moysidis, Dr, Euromedica Kyanos Stavros
  • Study Chair: Chrysa Papadopoulou, Euromedica Kyanos Stavros

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2025

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

March 30, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

March 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTeye adenoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parathyroid Adenoma

Clinical Trials on parathyroidectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe