Comparing PTeye-assisted Versus Conventional Total Thyroidectomy
Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial
The University of Hong Kong
210 participants
Sep 16, 2025
INTERVENTIONAL
Conditions
Summary
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surgery versus PTeye™-assisted surgery. Subjects will be assigned to the two groups before surgery. Subjects will be under medical care as in usual practice.
Eligibility
Inclusion Criteria3
- Adult patients ≥18 years of age
- Undergoing total thyroidectomy, or completion total thyroidectomy
- Pre-operative serum adjusted calcium levels within normal ranges
Exclusion Criteria5
- 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
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Interventions
The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07416149