NCT05152927

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice. PRIMARY OBJECTIVES: I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues. II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries. III. Assess the impact of PTeye on minimizing risk of post-surgical complications. Participants will be randomized to either the experimental or control arm. The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not. For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. Participants will be follow-ed up for up to 6 months after surgery.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Parathyroid Eye (PTeye)	Intraoperative Tool

Timeline

• Start date: 2022-01-10
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2021-12-10
• Last updated: 2025-12-15
• Results posted: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study