Comparing PTeye-assisted Versus Conventional Total Thyroidectomy

February 12, 2026 updated by: Man Him Matrix Fung, The University of Hong Kong

Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Man Him, Matrix Fung, MBBS
  • Phone Number: +852 2255 4232
  • Email: mmhfung@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Total thyroidectomy with the PTeye™ parathyroid detection system
PTeye™ assisted total thyroidectomy. PTeye will be used to identify the parathyroid glands early in the course of surgery.
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.
No Intervention: Conventional total thyroidectomy
Total thyroidectomy without PTeye™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
Time Frame: 6 months
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of inadvertent parathyroidectomy (in %)
Time Frame: within 4 weeks from operation
Rate of inadvertent parathyroidectomy (in %)
within 4 weeks from operation
Rate of parathyroid auto-transplantation (in %)
Time Frame: within operation
Rate of parathyroid auto-transplantation (in %)
within operation
Day 0 PTH
Time Frame: Post-operative Day 0
Day 0 Post-operative serum parathyroid hormone levels (pmol/L)
Post-operative Day 0
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Time Frame: Post-operative Day 1
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Post-operative Day 1
3-month Post-operative serum parathyroid hormone levels (pmol/L)
Time Frame: Post-operative 3 months
3-month Post-operative serum parathyroid hormone levels (pmol/L)
Post-operative 3 months
6-month Post-operative serum parathyroid hormone levels (pmol/L)
Time Frame: Post-operative 6 months
6-month Post-operative serum parathyroid hormone levels
Post-operative 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW-25-412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypocalcemia

Clinical Trials on PTeye™ parathyroid detection system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe