Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients ≥18 years of age
• Undergoing total thyroidectomy, or completion total thyroidectomy
• Pre-operative serum adjusted calcium levels within normal ranges
Locations
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Man Him, Matrix Fung, MBBS
mmhfung@hku.hk
+852 2255 4232
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 210
Treatments
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.
No_intervention: Conventional total thyroidectomy
Total thyroidectomy without PTeye™
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong