NCT06765941 PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial.
| NCT ID | NCT06765941 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Marcin Barczynski |
| Condition | Thyroid Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2025-08-23 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 154 participants in total. It began in 2025-08-23 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 D analogue fewer after thyroid operations with PTeye versus surgeon's naked eyes without PTeye in a short-term (\< 6 weeks) and/or in a long-term (at 6 months) follow-up? * Is numer of inadvertenly removed and reimplanted PGs fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of frozen sections fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of PGs identified by pathologist in the surgical specimen fewer in in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients with symptomatic hypoparathyroidism within 30 days of the operation fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? The hypothesis explored in this study is that use of PTeye in comparison to the surgeon's naked eyes may be beneficial for intraoperative identification and preservation of PGs in thyroid surgery leading to reduced risk of postoperative hypoparathyroidism. A prospective, randomized study with 2 arms: use of PTeye vs. visual identification of PGs without PTeye (n=77 patients, each). The primary outcome measure is number of intraoperatively identified PGs with use of PTeye vs without it.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06765941 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06765941 currently recruiting?
Yes, NCT06765941 is actively recruiting participants. Contact the research team at marbar@mp.pl for enrollment information.
Where is the NCT06765941 trial being conducted?
This trial is being conducted at Krakow, Poland.
Who is sponsoring the NCT06765941 clinical trial?
NCT06765941 is sponsored by Marcin Barczynski. The trial plans to enroll 154 participants.