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Thyroid DiseasesPTAIRNCT07628543

Computer Vision-Based Recognition of Parathyroid Glands and Recurrent Laryngeal Nerves in Endoscopic Surgery

An observational study of Thyroid Diseases and Thyroid Neoplasms, run by Fujian Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the performance of the PTAIR computer vision model for recognizing parathyroid glands and recurrent laryngeal nerves during endoscopic thyroid surgery. Multicenter intraoperative endoscopic surgery videos will be prospectively collected. Read more about this study

Who is it for?
Any age
Conditions the study is for
Thyroid Diseases, Thyroid Neoplasms
What is being tested?
PTAIR Computer Vision Model Assessment
How many people
100 participants
Where
1 siteChina
Study dates
1 Jun 2026to 31 May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population includes adult patients with benign or malignant thyroid disease who are scheduled to undergo endoscopic thyroid surgery at participating centers. Eligible patients will be prospectively enrolled during the study period if they meet the inclusion and exclusion criteria, agree to intraoperative video recording and research use, and have standardized recorder-based endoscopic surgical videos available. The study will evaluate PTAIR recognition performance for parathyroid glands and recurrent laryngeal nerves and compare it with recognition by junior and senior physicians based on the same intraoperative endoscopic visual field and the same video recording timeline.

Who may be able to join

  • Age 18 years or older.
  • Patients with benign or malignant thyroid disease who are scheduled to undergo endoscopic thyroid surgery.
  • Standardized recorder-based intraoperative video collection is planned during surgery.
  • Patients agree to intraoperative video recording, de-identification, and research use.
  • Basic perioperative clinical data are available.
  • The participating center is able to follow the standardized procedures for video collection, data upload, data security, and annotation quality control.

Who cannot join

  • Refusal to provide informed consent.
  • Patients scheduled to undergo conventional open thyroid surgery.
  • Standardized recorder-based intraoperative video collection cannot be performed.
  • Intraoperative video quality is insufficient for model analysis or expert review.
  • Key surgical phases are missing from the video recording.
  • Expert annotation or review of the parathyroid glands or recurrent laryngeal nerves cannot be completed.
Show all 9Show fewer
  • Video de-identification fails.
  • Severe missing perioperative clinical data.
  • Other conditions judged by the investigators to be unsuitable for study inclusion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bo Wang Professor, MD contact

86+13959123550

wangbo@fjmu.edu.cn

China1 site
  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Bo Wang Porfessor, MD, 86+13959123550, wangbo@fjmu.edu.cn

Other trials in China

About this study

Official title: Prospective Multicenter Model Validation Study of the PTAIR Computer Vision Model for Recognition of Parathyroid Glands and Recurrent Laryngeal Nerves During Endoscopic Thyroid Surgery

This study aims to evaluate the performance of the PTAIR computer vision model for recognizing parathyroid glands and recurrent laryngeal nerves during endoscopic thyroid surgery. Multicenter intraoperative endoscopic surgery videos will be prospectively collected. Using the video recorder timeline as the unified time reference, the first recognition time of parathyroid glands and recurrent laryngeal nerves by PTAIR, junior physicians, and senior physicians will be recorded during surgery. The continuous recognition time of parathyroid glands and recurrent laryngeal nerves by PTAIR will also be recorded.

This study focuses on the recognition performance of PTAIR in real-world multicenter endoscopic thyroid surgery settings. At this stage, PTAIR will not be used to guide intraoperative surgical decision-making, and the study will not evaluate the effect of PTAIR on clinical outcomes. The collected video data will be used to assess the performance of PTAIR under different centers, surgeons, equipment conditions, and surgical field conditions, and may provide data support for future model optimization.

Read the detailed description

Identification of the parathyroid glands and recurrent laryngeal nerves is an important component of safe thyroid surgery. Parathyroid glands are small and may resemble surrounding fat, lymph nodes, or soft tissue. The recurrent laryngeal nerve has a complex anatomical course and may be partially covered by fascia or insufficiently exposed in some cases, which may increase the difficulty of intraoperative recognition. Computer vision-based artificial intelligence models may help recognize these structures in endoscopic surgical images, but their performance in multicenter real-world surgical settings requires further validation.

Previous PTAIR studies mainly focused on parathyroid gland recognition in endoscopic thyroid surgery videos. Based on these prior studies, the present study will further evaluate the PTAIR model in a prospective multicenter setting, with a focus on recognition of parathyroid glands and recurrent laryngeal nerves. This stage of the study is designed as a model performance validation study and will not evaluate whether PTAIR changes intraoperative surgical decisions, parathyroid management, or postoperative clinical outcomes.

During endoscopic thyroid surgery, PTAIR, junior physicians, and senior physicians will identify parathyroid glands and recurrent laryngeal nerves based on the same intraoperative endoscopic visual field. All time-related outcomes will use the video recorder timeline as the unified reference. The study will record the first recognition time of the recurrent laryngeal nerve and parathyroid gland by PTAIR, junior physicians, and senior physicians, as well as the continuous recognition time of these structures by PTAIR. Expert-reviewed annotations will be used as the reference for subsequent model performance evaluation and confirmation of recognition results.

The study will also evaluate PTAIR performance under different exposure conditions, including cases with fascial coverage, incomplete exposure, or complex surgical field conditions. Multicenter video data will be used to assess model performance across different centers, surgeons, equipment settings, and operative field conditions, and may provide data for future model improvement and iteration.

Being tested
PTAIR Computer Vision Model Assessment
Keywords
PTAIR, Computer Vision, Endoscopic Thyroid Surgery, Parathyroid Gland Recognition, Recurrent Laryngeal Nerve Recognition, Model Validation
Medical subject headings
Thyroid Diseases, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTAIR Computer Vision Model AssessmentOther

    PTAIR is a computer vision model used to recognize parathyroid glands and recurrent laryngeal nerves in endoscopic thyroid surgery videos. In this observational study, PTAIR will be used to analyze recorder-based intraoperative videos and evaluate first recognition time, continuous recognition time, and recognition performance. PTAIR results will be compared with recognition by junior and senior physicians based on the same intraoperative endoscopic visual field and the same video recording timeline. At this stage, PTAIR will not be used to guide intraoperative surgical decision-making.

Study groups in NCT07628543
Study groupRoleWhat they receive
Multicenter Endoscopic Thyroid Surgery Video CohortThis cohort includes adult patients with thyroid disease who are scheduled to undergo endoscopic thyroid surgery and consent to intraoperative video recording and research use. Recorder-based intraoperative videos will be collected to evaluate the recognition performance of PTAIR for parathyroid glands and recurrent laryngeal nerves. The recognition results of PTAIR will be compared with those of junior and senior physicians based on the same intraoperative endoscopic visual field and the same video recording timeline.
Receives: Other: PTAIR Computer Vision Model Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First Recognition Time of the Recurrent Laryngeal Nerve

    Using the video recorder timeline as the unified time reference, the first recognition time of the recurrent laryngeal nerve by PTAIR, junior physicians, and senior physicians will be recorded during surgery. All recognitions will be based on the same intraoperative endoscopic visual field.

    Measured: Intraoperative period

  2. First Recognition Time of the Parathyroid Gland

    Using the video recorder timeline as the unified time reference, the first recognition time of the parathyroid gland by PTAIR, junior physicians, and senior physicians will be recorded during surgery. All recognitions will be based on the same intraoperative endoscopic visual field.

    Measured: Intraoperative period

  3. Continuous Recognition Time of the Recurrent Laryngeal Nerve

    Using the video recorder timeline as the unified time reference, the continuous recognition time of the recurrent laryngeal nerve by PTAIR will be recorded during surgery.

    Measured: Intraoperative period

  4. Continuous Recognition Time of the Parathyroid Gland

    Using the video recorder timeline as the unified time reference, the continuous recognition time of the parathyroid gland by PTAIR will be recorded during surgery.

    Measured: Intraoperative period

Secondary outcomes (6)
  1. AP50 for Recurrent Laryngeal Nerve Recognition

    Based on expert-reviewed annotations, AP50 will be calculated for PTAIR recognition of the recurrent laryngeal nerve. AP50 refers to the average precision at an intersection-over-union threshold of 0.50.

    Measured: From completion of intraoperative video collection to completion of expert annotation and model analysis

  2. AP50 for Parathyroid Gland Recognition

    Based on expert-reviewed annotations, AP50 will be calculated for PTAIR recognition of the parathyroid gland. AP50 refers to the average precision at an intersection-over-union threshold of 0.50.

    Measured: From completion of intraoperative video collection to completion of expert annotation and model analysis

  3. Comparison of First Recognition Time of the Recurrent Laryngeal Nerve Between PTAIR and Physicians

    The first recognition time of the recurrent laryngeal nerve will be compared among PTAIR, junior physicians, and senior physicians during surgery.

    Measured: Intraoperative period

  4. Comparison of First Recognition Time of the Parathyroid Gland Between PTAIR and Physicians

    The first recognition time of the parathyroid gland will be compared among PTAIR, junior physicians, and senior physicians during surgery.

    Measured: Intraoperative period

  5. In Situ Recognition Rate of the Parathyroid Gland

    Based on intraoperative videos and expert review, the in situ recognition rate of parathyroid glands by PTAIR will be recorded.

    Measured: From completion of intraoperative video collection to completion of expert review

  6. Detection Rate of Parathyroid Glands on the Surgical Specimen

    After completion of endoscopic dissection and before removal of the surgical specimen from the body, PTAIR will be used within the endoscopic visual field to examine whether parathyroid tissue is attached to or located around the surgical specimen. The detection result will be recorded.

    Measured: Intraoperative period, before removal of the surgical specimen from the body

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628543
Sponsor's protocol ID
PTAIR 3.0
Acronym
PTAIR
Status last verified
Jun 2026
First submitted
1 Jun 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang B, Zheng J, Yu JF, Lin SY, Yan SY, Zhang LY, Wang SS, Cai SJ, Abdelhamid Ahmed AH, Lin LQ, Chen F, Randolph GW, Zhao WX. Development of Artificial Intelligence for Parathyroid Recognition During Endoscopic Thyroid Surgery. Laryngoscope. 2022 Dec;132(12):2516-2523. doi: 10.1002/lary.30173. Epub 2022 May 31.

    PubMed 35638245
  • Wang B, Yu JF, Lin SY, Li YJ, Huang WY, Yan SY, Wang SS, Zhang LY, Cai SJ, Wu SB, Li MY, Wang TY, Abdelhamid Ahmed AH, Randolph GW, Chen F, Zhao WX. Intraoperative AI-assisted early prediction of parathyroid and ischemia alert in endoscopic thyroid surgery. Head Neck. 2024 Aug;46(8):1975-1987. doi: 10.1002/hed.27629. Epub 2024 Feb 13.

    PubMed 38348564

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Diseases and Thyroid Neoplasms, run by Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bo Wang Professor, MD (86+13959123550, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First Recognition Time of the Recurrent Laryngeal Nerve (time frame: Intraoperative period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07628543, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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