PTeye versus surgeon’s eye for finding and protecting parathyroid glands during total thyroid removal
Official title: Clinical Validation of Probe-based Parathyroid Autofluorescence Detection System PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial.
Run by Jagiellonian University · NCT06765941 · Data updated 2026-11-12
This trial will test whether using the PTeye near-infrared probe during first-time total thyroidectomy in adults helps surgeons find and preserve parathyroid glands better than using the surgeon’s naked eye.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 154 (estimated) |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow, Małopolska) |
| Status | Recruiting |
| Started | August 23, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT06765941 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with thyroid disease who are scheduled for a first-time total thyroidectomy and who can understand the protocol and attend postoperative follow-up are ideal candidates.
✕Probably not a fit
Patients with prior thyroid or parathyroid surgery, planned simultaneous parathyroid surgery, renal failure, pregnancy or lactation, allergy to iodine/contrast, or inability to complete follow-up are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, randomized (1:1) trial comparing use of a probe-based near-infrared autofluorescence device (PTeye) versus standard visual identification by the surgeon during total thyroidectomy. Patients are randomly assigned to PTeye-assisted surgery or to conventional visual identification, and surgeons record the number of parathyroid glands identified and preserved intraoperatively. Key outcomes include the number of glands identified/preserved, postoperative day 1 parathyroid hormone (PTH) levels, and need for calcium and vitamin D replacement in short-term (<6 weeks) and at 6-month follow-up. The planned sample size is 154 patients (77 per arm), accounting for expected dropout, based on a hypothesized increase in average glands identified from 2.5 to 3.5 with PTeye.
Why it matters
Potential benefit: If successful, using PTeye could reduce accidental parathyroid damage or removal and lower the rates of temporary or permanent postoperative hypoparathyroidism and need for calcium/vitamin D therapy.
How similar studies have gone: Previous smaller studies using near-infrared autofluorescence (including probe-based systems) have generally improved intraoperative detection of parathyroid glands, but evidence that this consistently reduces postoperative hypoparathyroidism is limited and mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * a patient with thyroid disease qualified for first-time total thyroidectomy. Exclusion Criteria: * history of thyroid or parathyroid surgery, * planned simultaneous thyroid and parathyroid surgery, * renal failure, * pregnancy, * lactation, * allergy to contrast agents and/or iodine, * inability of the patient to understand the study protocol, * inability to participate in the planned postoperative follow-up, * age below 18 years.
Where it's running
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Department of Endocrine Surgery, Faculty of Medicine, Jagiellonian University Medical College
Krakow, Małopolska, Poland Recruiting
Study contacts
- Study coordinator: Marcin Barczyński, MD, PhD
- Email: marbar@mp.pl
- Phone: 48123516663
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.