NCT05022641

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used. Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.

Detailed description

Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.

Conditions

• Parathyroid Adenoma
• Parathyroid Neoplasms
• Parathyroid Cancer
• Hypercalcemia
• Primary Hyperparathyroidism

Interventions

Type	Name	Description
DEVICE	PTeye	The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.
OTHER	Standard of Care	The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2021-08-26
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study