NCT07628543

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026May 2028

First Submitted

Initial submission to the registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

PTAIRComputer VisionEndoscopic Thyroid SurgeryParathyroid Gland RecognitionRecurrent Laryngeal Nerve RecognitionModel Validation

Outcome Measures

Primary Outcomes (4)

  • 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.

    Intraoperative period

  • 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.

    Intraoperative period

  • 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.

    Intraoperative period

  • 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.

    Intraoperative period

Secondary Outcomes (6)

  • AP50 for Recurrent Laryngeal Nerve Recognition

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

  • AP50 for Parathyroid Gland Recognition

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

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

    Intraoperative period

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

    Intraoperative period

  • In Situ Recognition Rate of the Parathyroid Gland

    From completion of intraoperative video collection to completion of expert review

  • +1 more secondary outcomes

Study Arms (1)

Multicenter Endoscopic Thyroid Surgery Video Cohort

This 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.

Other: PTAIR Computer Vision Model Assessment

Interventions

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.

Multicenter Endoscopic Thyroid Surgery Video Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Video de-identification fails.
  • Severe missing perioperative clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (2)

  • 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.

    PMID: 35638245BACKGROUND
  • 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.

    PMID: 38348564BACKGROUND

MeSH Terms

Conditions

Thyroid DiseasesThyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Study Officials

  • Bo Wang MD, Principal Investigator

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Wang Professor, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations