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Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

NCT05152927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-12-15

Study results available
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Summary

The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.

Conditions

  • Parathyroid Diseases
  • Parathyroid Dysfunction
  • Parathyroid Neoplasms
  • Parathyroid Adenoma
  • Hypercalcemia
  • Neoplasms, Glandular and Epithelial
  • Endocrine Gland Neoplasms
  • Adenoma
  • Hyperparathyroidism
  • Hyperparathyroidism, Primary

Interventions

DEVICE

Parathyroid Eye (PTeye)

Intraoperative Tool

Sponsors & Collaborators

Principal Investigators

  • Quan-Yang Duh, MD, FACS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT05152927 on ClinicalTrials.gov