At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
In Brief
A clinical study evaluating PTeye and Standard of Care for Parathyroid Adenoma and 4 related conditions. Completed, enrolled 160 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.