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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
PTeye™ parathyroid detection system
DeviceThe PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Total thyroidectomy with the PTeye™ parathyroid detection systemActive comparator 1 intervention
Group B: Conventional total thyroidectomyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
Time frame
6 monthsSecondary outcomes
1
Rate of inadvertent parathyroidectomy (in %)
Rate of inadvertent parathyroidectomy (in %)
Time frame
within 4 weeks from operation2
Rate of parathyroid auto-transplantation (in %)
Rate of parathyroid auto-transplantation (in %)
Time frame
within operation3
Day 0 PTH
Day 0 Post-operative serum parathyroid hormone levels (pmol/L)
Time frame
Post-operative Day 04
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Time frame
Post-operative Day 1Sponsors and contacts
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Source ClinicalTrials.gov