N/A
N=160
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Parathyroid Adenoma · Parathyroid Neoplasms · Parathyroid Cancer · Hypercalcemia · Primary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT05022641 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Average Number of Parathyroid Glands Identified — 2.7; 2.6 parathyroid glands per patient — p=.6
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PTeye (Device); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Parathyroid Glands Identified |
2.7; 2.6 | .6 |
| SECONDARY Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery |
23; 25.3 | .65 |
| SECONDARY Appropriate Intraoperative Parathyroid Hormone Drop |
45; 56; 35; 19 | .02 sig |
| SECONDARY Duration of Surgery |
92.3; 88.8 | 0.6 |
| SECONDARY Number of Nights Spent in the Hospital After Parathyroidectomy |
77; 76; 4; 3 | — |
| SECONDARY Number of Frozen Sections |
49; 47; 32; 32 | .6 |
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.
Eligibility Criteria
Inclusion Criteria
- Primary hyperparathyroidism who will be undergoing parathyroid surgery
- Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery
Exclusion Criteria
- Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.)
- Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
- Patients with secondary or tertiary hyperparathyroidism
Data sourced from ClinicalTrials.gov (NCT05022641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.