Comparing PTeye-assisted Versus Conventional Total Thyroidectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
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 groupsSponsors and collaborators
Source ClinicalTrials.gov