Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using PTeye to help protect parathyroid glands during total thyroidectomy

Official title: Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial

Run by The University of Hong Kong · NCT07416149 · Data updated 2026-11-12

This trial will test whether using the handheld PTeye device during total thyroidectomy in adults reduces the chance of low blood calcium after surgery.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment210 (estimated)
SponsorThe University of Hong Kong
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedSeptember 16, 2025
Main results expectedOctober 31, 2028
Study endsDecember 31, 2028
Registry record updatedFebruary 17, 2026
Trial IDNCT07416149 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) undergoing total or completion total thyroidectomy with normal preoperative adjusted calcium and not already taking calcium or vitamin D supplements are ideal candidates.

Probably not a fit

Patients with pre-existing parathyroid disease, untreated hyperparathyroidism, vitamin D deficiency, severe kidney failure (eGFR <30 or on dialysis), or those already on calcium/vitamin D supplements are excluded and unlikely to benefit.

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 prospective, single-blinded, randomized trial at a tertiary endocrine surgery unit in Hong Kong comparing conventional total thyroidectomy with PTeye-assisted surgery. PTeye is a probe-based near-infrared autofluorescence device used early in the operation to identify parathyroid glands by a quick touch of the probe. Consecutive adults undergoing total or completion thyroidectomy with normal preoperative calcium are randomized to PTeye-assisted or conventional surgery and receive usual postoperative care. The study tracks postoperative calcium and parathyroid function to see if PTeye reduces rates of transient and permanent hypoparathyroidism.

Why it matters

Potential benefit: If successful, PTeye use could lower rates of temporary and permanent low calcium after thyroid removal, reducing symptoms, hospital stays, and the need for long-term supplements.

How similar studies have gone: Near-infrared autofluorescence devices have shown promise in improving parathyroid identification and reducing transient postoperative low calcium in several studies, though results vary and randomized data specific to PTeye remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patients ≥18 years of age
* Undergoing total thyroidectomy, or completion total thyroidectomy
* Pre-operative serum adjusted calcium levels within normal ranges

Exclusion Criteria:

* Patients on pre-operative calcium or vitamin D supplements
* Patients with pre-operative vitamin D deficiency, defined as serum vitamin D\<30nmol/L
* Patients with untreated primary or secondary hyperparathyroidism
* Patient with known non-surgical hypoparathyroidism diseases
* Patients with estimated glomerular filtration rate \<30ml/1.73m2/min, on dialysis, or having a history of kidney transplant

Where it's running

  • Queen Mary Hospital
    Hong Kong, Hong Kong
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.