PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Par
The goal of this randomized clinical trial is to learn if there are any added benefits of using near-infrared autofluorescence (NIRAF) probe-based imaging system (the PTeye) for intraoperative identification of parathyroid glands (PGs) during thyroid surgery in comparison to visual identification of PGs by the surgeon'
| Condition(s) | Thyroid Surgery, Parathyroid Dysfunction, Hypoparathyroidism Post-surgical |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this randomized clinical trial is to learn if there are any added benefits of using near-infrared autofluorescence (NIRAF) probe-based imaging system (the PTeye) for intraoperative identification of parathyroid glands (PGs) during thyroid surgery in comparison to visual identification of PGs by the surgeon's naked eyes without PTeye. The main questions it aims to answer are: * Is number of PGs identified intraoperatively and preserved in situ larger in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients with undetectable or low parathormone serum level on postoperative day 1 fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients requiring substitution therapy with calcium and vitamin |
| Who can participate | Inclusion Criteria: * a patient with thyroid disease qualified for first-time total thyroidectomy. Exclusion Criteria: * history of thyroid or parathyroid surgery, * planned simultaneous thyroid and parathyroid surgery, * renal failure, * pregnancy, * lactation, * allergy to contrast agents and/or iodine, * inability of the patient to understand the study protocol, * inability to participate in the planned postoperative follow-up, * age below 18 years. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Marcin Barczynski |
| Locations | Krakow, Małopolska, Poland |
| Start date | 2025-08-23 |
| NCT ID | NCT06765941 |
| Official listing | https://clinicaltrials.gov/study/NCT06765941 |