Parathyroid AdenomaNCT06913296
PTeye in Parathyroid Adenoma
An observational study of Parathyroid Adenoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroid Adenoma
- What is being tested?
- parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 28 Mar 2025to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery for parathyroid adenoma
Who may be able to join
- Age >18 years old
- primary hyperparathyroidism caused by adenoma
- patient's informed consent acquired
Who cannot join
- Secondary and tertiary hyperparathyroidism
- Re-operation for adenoma
- Previous neck surgery
- Patient enrolled in another study that may affect the results of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Angeliki Chorti, Dr contact
Greece1 site, 1 recruiting
- Recruiting
Aristotle Univeristy of Thessaloniki
Thessaloniki, 54636
Theodossis Papavramidis, +306944536972, papavramidis@hotmail.com
Angeliki Chorti, Dr
About this study
Official title: 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.
Read the 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.
- Conditions
- Parathyroid Adenoma
- Being tested
- parathyroidectomy
- Keywords
- parathyroid adenoma, near-infrared autofluorescence
- Medical subject headings
- Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroidectomyProcedure or surgery
typical open parathyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: intraoperatively and 1st postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start28 Mar 2025
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Papavramidis Theodossis, Aristotle University Of Thessaloniki
- Investigators
- Moysis Moysidis, Dr, Study chair, Euromedica Kyanos StavrosChrysa Papadopoulou, Study chair, Euromedica Kyanos Stavros
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913296
- Sponsor's protocol ID
- PTeye adenoma
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do PTeye Score Correlate With Biochemical Markers in Parathyroid Adenoma?
- ClinicalTrials.gov ID
- NCT06913296
- Acronym / sponsor ID
- PTeye adenoma
- Conditions
- Parathyroid Adenoma
- Keywords
- parathyroid adenoma, near-infrared autofluorescence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parathyroid adenoma patients | – | Procedure: parathyroidectomyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for parathyroid adenoma
Key inclusion criteria (3 listed)
- Age >18 years old
- primary hyperparathyroidism caused by adenoma
- patient's informed consent acquired
Key exclusion criteria (4 listed)
- Secondary and tertiary hyperparathyroidism
- Re-operation for adenoma
- Previous neck surgery
- Patient enrolled in another study that may affect the results of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parathyroidectomytypical open parathyroidectomy | Procedure or surgery | Parathyroid adenoma patients |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angeliki Chorti, Dr contact
Moysis Moysidis, Dr study chair
Euromedica Kyanos Stavros
Chrysa Papadopoulou study chair
Euromedica Kyanos Stavros
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parathyroid Adenoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theodossis Papavramidis, Professor of Surgery (+306944536972, papavramidis@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the correlation of PTeye values with biochemical data (time frame: intraoperatively and 1st postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.