NCT07416149

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hypocalcemia
• Parathyroid
• Hypoparathyroidism Post-surgical
• Total Thyroidectomy

Interventions

Type	Name	Description
DEVICE	PTeye™ parathyroid detection system	The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.

Timeline

• Start date: 2025-09-16
• Primary completion: 2028-10-31
• Completion: 2028-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study