Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospectiv… (NCT06788223) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study
Greece40 participantsStarted 2024-11-01
Plain-language 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. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- Patients with Primary parathyroidism with parathyroid adenoma
Exclusion Criteria:
* Parathyroid Hyperplasia,
* Secondary hyperparathyroidism
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a light-based imaging tool called PTeye™ combined with a device called FLUOBEAM® LX to help surgeons spot parathyroid adenomas during the operation — how does that compare to how my surgeon would normally find the adenoma without this technology?
2Since this study is listed as 'active but no longer recruiting,' does that mean enrollment is closed and I wouldn't be able to join, or is there any chance my care team could still connect me with it or a similar imaging study?
3This trial focuses on whether the imaging tools can correctly identify the adenoma, but it doesn't seem to be measuring outcomes like calcium levels or cure rates after surgery — so how would my doctor know whether using this technology actually leads to a better result for me personally?
4Because this is listed as Phase NA — meaning it's more of a device evaluation study than a traditional drug trial — what is already known about the safety of these light-based imaging tools when used during parathyroid surgery?
5If I'm not able to participate in this trial, would my surgeon still have access to similar intraoperative imaging tools, or would my operation be done using standard visualization methods only?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of the parathyroid adenoma
Timeframe: The minute of the identification of the parathyroid adenoma (minute 0). Reevaluation in minutes 1, 3, and 5 during tissue dissection and before excision.