NCT06913296

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 30, 2025

Last Update Submit

March 30, 2025

Conditions

Keywords

parathyroid adenomanear-infrared autofluorescence

Outcome Measures

Primary Outcomes (1)

  • assess the correlation of PTeye values with biochemical data

    Biochemical data included are pre- and postoperative parathyroid hormone, serum calcium, phosphorus and vitamin D levels

    intraoperatively and 1st postoperative day

Study Arms (1)

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

Interventions

typical open parathyroidectomy

Parathyroid adenoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing surgery for parathyroid adenoma

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aristotle Univeristy of Thessaloniki

Thessaloniki, 54636, Greece

RECRUITING

MeSH Terms

Conditions

Parathyroid Neoplasms

Interventions

Parathyroidectomy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesParathyroid Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Moysis Moysidis, Dr

    Euromedica Kyanos Stavros

    STUDY CHAIR
  • Chrysa Papadopoulou

    Euromedica Kyanos Stavros

    STUDY CHAIR

Central Study Contacts

Theodossis Papavramidis, Professor of Surgery

CONTACT

Angeliki Chorti, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 6, 2025

Study Start

March 28, 2025

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations