NIRAF-guided identification of parathyroids during thyroidectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a wearable, label-free NIRAF imaging system that uses goggles to visualize parathyroid autofluorescence during thyroidectomy. Component A examines ex vivo specimens for imaging and pathology correlation in 30 participants. Component B randomizes up to 250 adults to standard thyroidectomy versus standard thyroidectomy with brief intraoperative NIRAF imaging, to see if the technique reduces early biochemical hypoparathyroidism. No dye is injected, and fluorescence is used to aid surgical judgment along with standard care. The primary outcome is the rate of early hypoparathyroidism defined by serum intact PTH levels.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older.
* For Component A: planned thyroidectomy of any extent with an intact specimen available for ex vivo evaluation.
* For Component B: planned total or completion thyroidectomy.
* Ability to provide written informed consent before surgery.
* For Component B: willingness to undergo the scheduled laboratory assessments and follow-up through six months, in addition to clinically indicated postoperative care.

Exclusion Criteria:

* Known pre-existing hypoparathyroidism or prior parathyroid surgery.
* Severe chronic kidney disease or end-stage renal disease expected to substantially confound calcium and parathyroid hormone interpretation, as defined by the site investigator.
* Pregnancy.
* For Component B only: gross nodal disease or a surgical plan requiring extensive nodal packet dissection in the current study phase.
* Any condition that, in the judgment of the investigator, would make participation unsafe or compromise protocol adherence.

Where it's running

• University Clinic Hospital
  Skopje, North Macedonia Recruiting

Study contacts

• Principal investigator: Magdalena Bogdanovska Todorovska, MD, PhD — Ss. Cyril and Methodius University of Skopje
• Study coordinator: Magdalena Bogdanovska Todorovska, MD, PhD
• Email: magdalena.todorovska@medf.ukim.edu.mk
• Phone: +389-70960221

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.