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NCT06765941: PTSURGEYE
PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial.
NA trial testing Probe-based near-infrared parathyroid autofluorescence detection system in Thyroid Surgery in 154 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Marcin Barczynski |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 154 |
| Start date | 23 August 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 30 June 2026 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Probe-based near-infrared parathyroid autofluorescence detection system
- Surgeons naked eyes for parathyroid glands identification
Conditions studied
- Thyroid Surgery — all drugs for Thyroid Surgery →
- Parathyroid Dysfunction — all drugs for Parathyroid Dysfunction →
- Hypoparathyroidism Post-surgical — all drugs for Hypoparathyroidism Post-surgical →
Sponsor
Marcin Barczynski
Who can join
18 and older, any sex, with Thyroid Surgery or Parathyroid Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06765941
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Thyroid Surgery
Currently open trials in the same condition.
- NCT07010341 — Quantitative Intra-operative Assessment of Parathyroid Perfusion Using Indocyanine Green (ICG) Fluorescence Imaging · recruiting
- NCT06917755 — The Impact of Immersive Virtual Reality Training in Thyroid Surgery · NA · recruiting
- NCT06838728 — The Effect of the Application of Head Mounted Magnifying Glasses on Postoperative PTH Changes in Thyroid Surgery: Stage · NA · active not recruiting
Other Marcin Barczynski trials
Trials by the same sponsor.
- NCT06289309 — NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery · NA · unknown
- NCT04794257 — NerveTrend vs. i-IONM in Prevention of Recurrent Laryngeal Nerve Events During Bilateral Thyroid Surgery. · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06765941 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Marcin Barczynski
- Last refreshed: 2 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06765941.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing