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Comparing PTeye-assisted Versus Conventional Total Thyroidectomy

NCT07416149 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-02-17

No results posted yet for this study

Summary

This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surgery versus PTeye™-assisted surgery. Subjects will be assigned to the two groups before surgery. Subjects will be under medical care as in usual practice.

Conditions

  • Hypocalcemia
  • Parathyroid
  • Hypoparathyroidism Post-surgical
  • Total Thyroidectomy

Interventions

DEVICE

PTeye™ parathyroid detection system

The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2028-10-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416149 on ClinicalTrials.gov