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Search / Trial NCT06765941

PTeye Vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: a Parallel Randomized Controlled Clinical Trial.

Launched by MARCIN BARCZYNSKI · Jan 5, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Thyroid Surgery Postoperative Hypoparathyroidism Near Infrared Autofluorescence P Teye Probe Based Parathyroid Detection Visual Identification

ClinConnect Summary

This clinical trial is studying a new tool called PTeye, which uses special imaging technology to help surgeons see and identify parathyroid glands during thyroid surgery. The main goal is to find out if using PTeye can lead to better identification and preservation of these glands compared to the traditional method where surgeons rely only on their eyesight. The researchers want to see if patients who have surgery with PTeye end up with fewer complications, such as low parathyroid hormone levels or needing additional treatments for calcium and vitamin D after surgery.

To participate in this trial, patients must be adults aged 18 and older who are scheduled for their first total thyroidectomy (removal of the thyroid gland) due to thyroid disease. Some individuals, like those with a history of thyroid or parathyroid surgery, renal failure, or pregnancy, will not be eligible. Participants will be randomly assigned to either the PTeye group or the traditional surgery group and will be monitored for their recovery and any complications. The hope is that using PTeye will help improve patient outcomes and reduce the risk of problems after surgery.

Gender

ALL

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.

About Marcin Barczynski

Marcin Barczyński is a distinguished clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the pharmaceutical and biotechnology sectors, he focuses on innovative trial designs that enhance the efficiency and efficacy of clinical studies. His leadership emphasizes rigorous adherence to regulatory standards and ethical practices, ensuring the integrity of data collection and participant safety. Barczyński's collaborative approach fosters partnerships with research institutions and healthcare providers, driving forward the development of groundbreaking therapies and treatments.

Locations

Kraków, Małopolska, Poland

Kraków, , Poland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported