PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial. (PTSURGEYE)

August 25, 2025 updated by: Marcin Barczynski

Clinical Validation of Probe-based Parathyroid Autofluorescence Detection System PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A single-center prospective study with 1:1 randomization and a control group. It was assumed that it is possible to visually identify 2-3 (average 2.5) out of 4 PGs (62.5%), and that the use of the PTeye probe will increase the number of identified PGs to 3-4 (average 3.5) out of 4 (87, 5%). The statistical power for p<0.05 and 90% sensitivity of the study designed in this way is 122 patients (61 in each group), and taking into account the 20% risk of patients withdrawal or dropping out from the study, the required number is 154 patients, 77 patients in each group.

Inclusion criterion: 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.

Included patients will be randomly assigned to the study group (thyroid surgery with the PTeye device) or the control group (thyroid surgery without the device).

Randomization will be performed on the Eurocrine platform. The PTeye device will be used in the study group for intraoperative identification of the PGs. In the control group, the PGs will be identified using the classic technique based on visual identification with naked eyes.

For patients assigned to the study arm with PTeye:

The surgeon will use the PTeye as an intraoperative tool to identify whether a suspect tissue is parathyroid or not during the surgery. The surgeon will first take five baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent), to establish a reference point for subsequent measurements, using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step involves touching the target tissue in the neck with the fiber optic probe, after which the PTeye will indicate to the surgeon whether the tissue is parathyroid or not. Parameters displayed on the PTeye console - Baseline values, Detection Intensity, Parathyroid Detection Ratio - will be recorded for each patient in the study arm. PTeye indicates that a tissue is parathyroid if the 'Parathyroid Detection Ratio' is greater than 1.2. The rest of the surgical procedure will follow the standard protocol. At the end of the procedure, the thyroid specimen will be evaluated with the PTeye to search for inadvertently resected parathyroid glands. If found, these parathyroid glands will be reimplanted in the sternocleidomastoid muscle, following standard protocol.

For patients assigned to the control arm without PTeye:

The surgeon will not use the PTeye and will proceed with the procedure as usual, relying on their surgical experience to identify parathyroid glands. At the end of the procedure, the thyroid specimen will be evaluated visually to search for inadvertently resected parathyroid glands. If this is the case, these parathyroid glands will be reimplanted in the sternocleidomastoid muscle, following standard protocol.

Preoperative, intraoperative, and postoperative parameters measured for all patients:

The following data will be compiled for all enrolled patient: patient demographics, duration of surgery, number of frozen section analyses performed, frozen section and permanent histology reports of all excised tissues, blood calcium levels (before surgery, on 1st post-operative day, on 1st postoperative visit after surgery, and at 6 months after surgery (if followed up)), parathyroid hormone (PTH) serum levels (on 1st post-operative day, on 1st postoperative visit after surgery, and at 6 months after surgery (if followed up)), history and duration of calcium and/or Vitamin D supplementation before and after surgery, and postsurgical complications, if any, and history of emergency room visits or hospitalization.

These preoperative, intraoperative, and postoperative investigations will be performed at the surgeon's discretion as necessary for the patient and as standard management for patients with thyroid pathologies. These parameters will then be compared between the study arm and the control arm to gauge the impact or value of PTeye suystem for thyroid surgeries.

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marcin Barczyński, MD, PhD
  • Phone Number: 48123516663
  • Email: marbar@mp.pl

Study Contact Backup

  • Name: Aleksander Konturek, MD, PhD
  • Phone Number: 48123516663
  • Email: okont@mp.pl

Study Locations

  • Poland
    • Małopolska
      • Krakow, Małopolska, Poland, 31-501
        • Recruiting
        • Department of Endocrine Surgery, Faculty of Medicine, Jagiellonian University Medical College
        • Principal Investigator:
          • Marcin Barczyński, MD, PhD
        • Contact:
          • Marcin Barczyński, MD, PhD
          • Phone Number: 48123516661
          • Email: marbar@mp.pl
        • Contact:
          • Aleksander Konturek, MD, PhD
          • Phone Number: 48123516661
          • Email: okont@mp.pl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thyroid operations with PTeye system for parathyroid glands identification
Device: Probe-based near-infrared parathyroid autofluorescence detection system
The surgeon will use the PTeye as an intraoperative tool to identify whether a suspect tissue is parathyroid or not during the surgery. The surgeon will first take five baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent), to establish a reference point for subsequent measurements, using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step involves touching the target tissue in the neck with the fiber optic probe, after which the PTeye will indicate to the surgeon whether the tissue is parathyroid or not. Parameters displayed on the PTeye console - Baseline values, Detection Intensity, Parathyroid Detection Ratio - will be recorded for each patient in the study arm. PTeye indicates that a tissue is parathyroid if the 'Parathyroid Detection Ratio' is greater than 1.2. The rest of the surgical procedure will follow the standard protocol.
Active Comparator: Thyroid operations with surgeons naked eyes for parathyroid glands identification without PTeye
Procedure: Surgeons naked eyes for parathyroid glands identification
The surgeons will not use the probe-based near-infrared parathyroid autofluorescence detection system and will proceed with the procedure as usual, relying on their surgical experience to identify parathyroid glands. At the end of the procedure, the thyroid specimen will be evaluated visually to search for inadvertently resected parathyroid glands. If this is the case, these parathyroid glands will be reimplanted in the sternocleidomastoid muscle, following standard protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of intraoperatively identified parathyroid glands
Time Frame: During thyroid operation
During thyroid operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Numer of inadvertenly removed and reimplanted parathyroid glands
Time Frame: During thyroid surgery
During thyroid surgery
Number of frozen sections
Time Frame: During thyroid surgery
During thyroid surgery
Numer of patients with undetectable or low parathormone serum level
Time Frame: Postoperative day 1
Postoperative day 1
Number of parathyroid glands identified by pathologist in the surgical specimen
Time Frame: Within 30 days postoperatively
Within 30 days postoperatively
Number of patients requiring substitution therapy with calcium and vitamin D analogue
Time Frame: At 30 days postoperatively
At 30 days postoperatively
Number of patients with symptomatic hypoparathyroidism
Time Frame: Within 30 days postoperatively
Within 30 days postoperatively
Number of patients requiring substitution therapy with calcium and vitamin D analogue
Time Frame: At 6 months postoperatively
At 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marcin Barczynski

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N41/DBS/001474

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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