An interventional study of PTeye™ parathyroid detection system in Hypocalcemia, Parathyroid and Hypoparathyroidism Post-surgical, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
Post-operative hypoparathyroidism (PH) is a debilitating complication following total thyroidectomy. It arises from inadvertent removal or devascularization of the parathyroid glands. From a previous study in Hong Kong and other population-wide series, permanent PH rates could be as high as 11%, and transient PH rates being 30-48%, posing substantial burden on healthcare systems.
Near-infrared autofluorescence (NIRAF) technology has emerged to assist the identification and preservation of parathyroid glands during surgery. This study investigates the probe-based NIRAF device, PTeye™, which emits laser and receives NIR real-time, thereby detecting parathyroid glands by a simple touch of a probe.
A standardized protocol is devised to use PTeye™ for parathyroid identification at the early stage of surgery, in order to avoid devascularization or inadvertent removal of the parathyroids.
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce PH. The study will enroll consecutive patients undergoing total thyroidectomy in a tertiary endocrine surgery unit in Hong Kong. Patients will be randomized to receive conventional surgery or PTeye™-assisted surgery.
Exclusion Criteria:
PTeye™ assisted total thyroidectomy. PTeye will be used to identify the parathyroid glands early in the course of surgery.
Device: PTeye™ parathyroid detection system
Total thyroidectomy without PTeye™
The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
Time frame: 6 months
Rate of inadvertent parathyroidectomy (in %)
Rate of inadvertent parathyroidectomy (in %)
Time frame: within 4 weeks from operation
Rate of parathyroid auto-transplantation (in %)
Rate of parathyroid auto-transplantation (in %)
Time frame: within operation
Day 0 PTH
Day 0 Post-operative serum parathyroid hormone levels (pmol/L)
Time frame: Post-operative Day 0
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Time frame: Post-operative Day 1
3-month Post-operative serum parathyroid hormone levels (pmol/L)
3-month Post-operative serum parathyroid hormone levels (pmol/L)
Time frame: Post-operative 3 months
6-month Post-operative serum parathyroid hormone levels (pmol/L)
6-month Post-operative serum parathyroid hormone levels
Time frame: Post-operative 6 months
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The University of Hong Kong