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

NCT06765941 | Recruiting FDA Device

• 1 other identifier: N41/DBS/001474
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Surgery; Parathyroid Dysfunction; Hypoparathyroidism Post-surgical

Keywords

thyroid surgery; postoperative hypoparathyroidism; near-infrared autofluorescence; PTeye; probe-based parathyroid detection; visual identification

Outcome Measures

Primary Outcomes (1)

• Number of intraoperatively identified parathyroid glands

  During thyroid operation

Secondary Outcomes (7)

• Numer of inadvertenly removed and reimplanted parathyroid glands

  During thyroid surgery

• Number of frozen sections

  During thyroid surgery

• Numer of patients with undetectable or low parathormone serum level

  Postoperative day 1

• Number of parathyroid glands identified by pathologist in the surgical specimen

  Within 30 days postoperatively

• Number of patients requiring substitution therapy with calcium and vitamin D analogue

  At 30 days postoperatively

Study Arms (2)

Thyroid operations with PTeye system for parathyroid glands identification

EXPERIMENTAL

Device: Probe-based near-infrared parathyroid autofluorescence detection system

Thyroid operations with surgeons naked eyes for parathyroid glands identification without PTeye

ACTIVE COMPARATOR

Procedure: Surgeons naked eyes for parathyroid glands identification

Interventions

Probe-based near-infrared parathyroid autofluorescence detection system DEVICE

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.

Thyroid operations with PTeye system for parathyroid glands identification

Surgeons naked eyes for parathyroid glands identification PROCEDURE

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.

Thyroid operations with surgeons naked eyes for parathyroid glands identification without PTeye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a patient with thyroid disease qualified for first-time total thyroidectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marcin Barczynski: lead

Study Sites (1)

Department of Endocrine Surgery, Faculty of Medicine, Jagiellonian University Medical College

Krakow, Małopolska, 31-501, Poland

RECRUITING

Related Publications (9)

• Abood A, Rolighed L, Ovesen T, Madsen SH, Vestergaard P, Triponez F. Autofluorescence-guided hemithyroidectomy in a low-volume thyroid institution with no experience in parathyroid surgery: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae075. doi: 10.1093/bjs/znae075.

  PMID: 38573333 BACKGROUND

• Vetter D, Triponez F. Near-infrared fluorescence techniques to reduce hypocalcaemia after thyroidectomy. Br J Surg. 2023 Nov 9;110(12):1590-1593. doi: 10.1093/bjs/znad221. No abstract available.

  PMID: 37463423 BACKGROUND

• Vidal Fortuny J, Belfontali V, Sadowski SM, Karenovics W, Guigard S, Triponez F. Parathyroid gland angiography with indocyanine green fluorescence to predict parathyroid function after thyroid surgery. Br J Surg. 2016 Apr;103(5):537-43. doi: 10.1002/bjs.10101. Epub 2016 Feb 11.

  PMID: 26864909 BACKGROUND

• Bergenfelz A, Barczynski M, Heie A, Muth A, Passler C, Schneider M, Wierzbicka P, Konturek A, Brauckhoff K, Elf AK, Dahlberg J, Hermann M. Impact of autofluorescence for detection of parathyroid glands during thyroidectomy on postoperative parathyroid hormone levels: parallel multicentre randomized clinical trial. Br J Surg. 2023 Nov 9;110(12):1824-1833. doi: 10.1093/bjs/znad278.

  PMID: 37758507 BACKGROUND

• Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chereau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613.

  PMID: 31693081 BACKGROUND

• Thomas G, Squires MH, Metcalf T, Mahadevan-Jansen A, Phay JE. Imaging or Fiber Probe-Based Approach? Assessing Different Methods to Detect Near Infrared Autofluorescence for Intraoperative Parathyroid Identification. J Am Coll Surg. 2019 Dec;229(6):596-608.e3. doi: 10.1016/j.jamcollsurg.2019.09.003. Epub 2019 Sep 25.

  PMID: 31562910 BACKGROUND

• Thomas G, McWade MA, Nguyen JQ, Sanders ME, Broome JT, Baregamian N, Solorzano CC, Mahadevan-Jansen A. Innovative surgical guidance for label-free real-time parathyroid identification. Surgery. 2019 Jan;165(1):114-123. doi: 10.1016/j.surg.2018.04.079. Epub 2018 Nov 12.

  PMID: 30442424 BACKGROUND

• Thomas G, McWade MA, Paras C, Mannoh EA, Sanders ME, White LM, Broome JT, Phay JE, Baregamian N, Solorzano CC, Mahadevan-Jansen A. Developing a Clinical Prototype to Guide Surgeons for Intraoperative Label-Free Identification of Parathyroid Glands in Real Time. Thyroid. 2018 Nov;28(11):1517-1531. doi: 10.1089/thy.2017.0716. Epub 2018 Sep 11.

  PMID: 30084742 BACKGROUND

• Paras C, Keller M, White L, Phay J, Mahadevan-Jansen A. Near-infrared autofluorescence for the detection of parathyroid glands. J Biomed Opt. 2011 Jun;16(6):067012. doi: 10.1117/1.3583571.

  PMID: 21721833 BACKGROUND

MeSH Terms

Conditions

Parathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Central Study Contacts

Marcin Barczyński, MD, PhD

CONTACT

48123516663; marbar@mp.pl

Aleksander Konturek, MD, PhD

CONTACT

48123516663; okont@mp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Department of Endocrine Surgery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: August 23, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)