Health Trials

About this 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.

Eligibility criteria

Qualifiers

Adult patients ≥18 years of age

Undergoing total thyroidectomy, or completion total thyroidectomy

Pre-operative serum adjusted calcium levels within normal ranges

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PTeye™ parathyroid detection system

Treatment groups

210 Participants
are divided into 2 treatment groups

Locations

1
Queen Mary Hospital Hong Kong Hong Kong

Sponsors and collaborators

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov