PTeye in Parathyroid Adenoma | NCT06913296

Studies
PTeye in Parathyroid Adenoma

NCT06913296

Sponsor

Aristotle University Of Thessaloniki

Status

Recruiting

Last Update Posted

Apr 6, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Parathyroid Adenoma

Interventions

parathyroidectomy

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2025Actual

Primary Completion Date

May 30, 2025Estimated

Completion Date

May 30, 2025Estimated

First Submitted Date

Mar 30, 2025

First Submission Date that Met QC Criteria

Mar 30, 2025

First Posted Date

Apr 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2025

Last Update Posted Date

Apr 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Papavramidis Theodossis, Professor of Surgery, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
parathyroidectomy	Procedure	typical open parathyroidectomy	Parathyroid adenoma patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing surgery for parathyroid adenoma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Theodossis Papavramidis, Professor of Surgery	Contact	+306944536972		papavramidis@hotmail.com
Angeliki Chorti, Dr	Contact			chorange2404@gmail.com

Overall Officials

Name	Affiliation	Role
Moysis Moysidis, Dr	Euromedica Kyanos Stavros	Study Chair
Chrysa Papadopoulou	Euromedica Kyanos Stavros	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aristotle Univeristy of Thessaloniki	Recruiting	Thessaloniki		54636	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010282	Parathyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016105	Parathyroidectomy

Ancestor Terms

ID	Term
D013507	Endocrine Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided