What is the PTeye™ device studying for post-operative hypoparathyroidism?

The PTeye™ device is being studied to see if it can reduce hypoparathyroidism after total thyroidectomy by helping surgeons identify parathyroid glands during surgery. This research is conducted by The University of Hong Kong to improve surgical outcomes and reduce complications for patients undergoing thyroid removal.

Who may be eligible for this hypoparathyroidism clinical trial?

Adults 18 years and older undergoing total or completion thyroidectomy may be eligible. Participants must have normal pre-operative calcium levels and not be taking calcium or vitamin D supplements. People with certain conditions like vitamin D deficiency or kidney issues are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this hypoparathyroidism clinical trial?

Study-related care, including the device and all trial visits, is provided at no cost. However, personal travel expenses to and from the study site may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07416149

Randomized Trial Comparing PTeye-Assisted Versus Conventional Total Thyroidectomy to Reduce Post-Operative Hypoparathyroidism

Led by The University of Hong Kong · Updated on 2026-02-17

210

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Post-operative hypoparathyroidism PH is a challenging complication following total thyroidectomy, caused by accidental removal or damage to the parathyroid glands. Researchers are evaluating whether the PTeye device, which uses near-infrared autofluorescence NIRAF technology, can help reduce PH by better identifying these glands during surgery. This prospective, single-blinded, randomized controlled trial enrolls patients undergoing total thyroidectomy at a tertiary endocrine surgery unit in Hong Kong. Participants will be randomly assigned to one of two groups one receiving conventional total thyroidectomy and the other undergoing surgery assisted by the PTeye parathyroid detection system. PTeye uses a probe that emits laser and detects near-infrared signals in real time to identify parathyroid glands early during the operation, aiming to avoid their inadvertent removal or devascularization. During the study, participants will receive medical care as usual. Researchers will measure the rate of significant post-operative hypoparathyroidism six months after surgery, along with secondary outcomes such as rates of unintended parathyroid removal, parathyroid auto-transplantation, and parathyroid hormone levels on the day of surgery, the following day, and at three and six months post-operation. The trial starts in September 2025 and continues until December 2028.

CONDITIONS

Brief Title

Comparing PTeye-assisted Versus Conventional Total Thyroidectomy

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

Patients taking pre-operative calcium or vitamin D supplements
Patients with pre-operative vitamin D deficiency (serum vitamin D below 30 nmol/L)
Patients with untreated primary or secondary hyperparathyroidism
Patients with known non-surgical hypoparathyroidism diseases
Patients with estimated glomerular filtration rate below 30 ml/1.73m2/min, on dialysis, or with a history of kidney transplant

Research Team

Man Him, Matrix Fung, MBBS

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