Primary Hyperparathyroidism Due to AdenomaPTeyeNCT06788223
Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study
An observational study of Primary Hyperparathyroidism Due to Adenoma, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The goal of this observational study is to evaluate the efficacy of PTeyeTM device to confirm a parathyroid adenoma on a visually suspected tissue in comparison with the FLUOBEAM®LX device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Hyperparathyroidism Due to Adenoma
- What is being tested?
- Parathyroidectomy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2024to 31 Jan 2025
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary hyperparathyroidism and parathyroid adenoma, fulfilling the AAES guidelines indications for parathyroidectomy.
Who may be able to join
- Patients with Primary parathyroidism with parathyroid adenoma
Who cannot join
- Parathyroid Hyperplasia,
- Secondary hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to evaluate the efficacy of PTeyeTM device to confirm a parathyroid adenoma on a visually suspected tissue in comparison with the FLUOBEAM®LX device. The main questions it aims to answer is:
Is the PTeyeTM device effective in identifying the presence of a parathyroid adenoma? Which autofluorecence device (PTeye or FLUOBEAM®LX) is more effective in confirming the presence of a parathyroid adenoma? Participants will undergo parathyroidectomy under general anesthesia. During the procedure visually suspected tissue for parathyroid adenoma will be evaluated with the PTeye or FLUOBEAM®LX device for the presence of an adenoma (minute 0). Tissue will be reevaluated on minutes 1, 3, and 5 and before excision.
Read the detailed description
Objective: PTeye™ and FLUOBEAM® LX use autofluorescence to confirm visually suspected parathyroid tissue. Real-time intraoperative identification of parathyroid glands can be achieved by the application of both devices. The aim of the present study is to evaluate and compare the efficacy of PTeye™ and FLUOBEAM® LX in identifying parathyroid adenomas.
Methods: Patients undergoing parathyroidectomy due to a parathyroid adenoma will be enrolled prospectively in this study and will be randomly included to Group A (PTeye™) or Group B (FLUOBEAM® LX). After intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0), the efficacy of both devices to confirm the adenomas will be evaluated. Re-evaluation will take place in minutes 1, 3 and 5 during tissue dissection and before adenoma excision.
- Being tested
- Parathyroidectomy
- Medical subject headings
- Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParathyroidectomyDevice
Parathyroidectomy under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| PTeye | Localizing Parathyroid adenoma with the PTeye device during parathyroidectomy Receives: Device: Parathyroidectomy | |
| Fluobeam | Localizing Parathyroid adenoma with the Fluobeam/ Fluoptics device Receives: Device: Parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the parathyroid adenoma
The percentage of adenomas identified by each device is assessed after intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0).
The same percentage will be re-evaluated on minutes 1, 3 and 5 during tissue dissection and before adenoma excision.
Measured: The minute of the identification of the parathyroid adenoma (minute 0). Reevaluation in minutes 1, 3, and 5 during tissue dissection and before excision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Nov 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Hyperparathyroidism Due to AdenomaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
- Target duration
- 1 Day
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788223
- Sponsor's protocol ID
- PTeye
- Acronym
- PTeye
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06788223
- Acronym / sponsor ID
- PTeye / PTeye
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 23 Jan 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.
The goal of this observational study is to evaluate the efficacy of PTeyeTM device to confirm a parathyroid adenoma on a visually suspected tissue in comparison with the FLUOBEAM®LX device. The main questions it aims to answer is:
Is the PTeyeTM device effective in identifying the presence of a parathyroid adenoma? Which autofluorecence device (PTeye or FLUOBEAM®LX) is more effective in confirming the presence of a parathyroid adenoma? Participants will undergo parathyroidectomy under general anesthesia. During the procedure visually suspected tissue for parathyroid adenoma will be evaluated with the PTeye or FLUOBEAM®LX device for the presence of an adenoma (minute 0). Tissue will be reevaluated on minutes 1, 3, and 5 and before excision.
Detailed description
Objective: PTeye™ and FLUOBEAM® LX use autofluorescence to confirm visually suspected parathyroid tissue. Real-time intraoperative identification of parathyroid glands can be achieved by the application of both devices. The aim of the present study is to evaluate and compare the efficacy of PTeye™ and FLUOBEAM® LX in identifying parathyroid adenomas.
Methods: Patients undergoing parathyroidectomy due to a parathyroid adenoma will be enrolled prospectively in this study and will be randomly included to Group A (PTeye™) or Group B (FLUOBEAM® LX). After intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0), the efficacy of both devices to confirm the adenomas will be evaluated. Re-evaluation will take place in minutes 1, 3 and 5 during tissue dissection and before adenoma excision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTeye | – | Device: ParathyroidectomyLocalizing Parathyroid adenoma with the PTeye device during parathyroidectomy |
| Fluobeam | – | Device: ParathyroidectomyLocalizing Parathyroid adenoma with the Fluobeam/ Fluoptics device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary hyperparathyroidism and parathyroid adenoma, fulfilling the AAES guidelines indications for parathyroidectomy.
Key inclusion criteria (1 listed)
- Patients with Primary parathyroidism with parathyroid adenoma
Key exclusion criteria (2 listed)
- Parathyroid Hyperplasia,
- Secondary hyperparathyroidism
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 |
|---|---|---|
| ParathyroidectomyParathyroidectomy under general anesthesia | Device | Fluobeam, PTeye |
Primary outcome
Identification of the parathyroid adenoma
Time frame: The minute of the identification of the parathyroid adenoma (minute 0). Reevaluation in minutes 1, 3, and 5 during tissue dissection and before excision.
The percentage of adenomas identified by each device is assessed after intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0). The same percentage will be re-evaluated on minutes 1, 3 and 5 during tissue dissection and before adenoma excision.
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 24 Jan 2025.
- Individual participant dataSharing planned: Yes. Upon request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary Hyperparathyroidism Due to 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 24 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the parathyroid adenoma (time frame: The minute of the identification of the parathyroid adenoma (minute 0). Reevaluation in minutes 1, 3, and 5 during tissue dissection and before excision.). 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 24 Jan 2025.