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.
98 studies on the registry are indexed under Hypocalcemia; 16 are open to participants now.
This study's planned enrollment of 210 is above the median of 84 across 66 interventional studies indexed under Hypocalcemia.
Browse Hypocalcemia studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Plan to share: Undecided
Started Sep 2025 (actual). Primary completion is estimated for Oct 2028, 37 months after the start.
Of 20 interventional studies with no phase under Hypocalcemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 39. This study's planned 37 months is above that.
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