N/A
Completed N=79
Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Parathyroid Diseases · Parathyroid Dysfunction · Thyroid Cancer · Parathyroid Adenoma
Source: ClinicalTrials.gov NCT05152927 ↗
Enrolled (actual)
79
Serious AEs
8.9%
Results posted
Dec 2025
Primary outcomePrimary: Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis — 0; 0 frozen aspirate samples
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis |
0; 0 | — |
| SECONDARY Number of Participants With Persistent Hyperparathyroidism (Immediate) |
0; 1 | — |
| SECONDARY Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient) |
0; 0 | — |
| SECONDARY Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy) |
0; 1 | — |
| SECONDARY Number of Parathyroid Glands (PG) Identified |
45; 45 | — |
| SECONDARY Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only) |
1 | — |
| SECONDARY Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands |
1; 1; 1; 1 | — |
| SECONDARY Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent |
5; 5 | — |
| SECONDARY Median Duration Taken to Identify First Parathyroid Gland |
38; 31 | — |
| SECONDARY Median Duration Taken to Identify Last Parathyroid Gland |
48; 35 | — |
| SECONDARY Median Duration of Parathyroidectomy (PTx) Procedure |
87; 82 | — |
| SECONDARY Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize |
76; 66 | — |
| SECONDARY Median Number of Nights in the Hospital After Parathyroidectomy |
0; 0; 1; 1 | — |
| SECONDARY Median Number of 'False Positive' Tissue Samples Excised by Surgeon |
0; 0 | — |
| SECONDARY Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions |
5; 8 | — |
| SECONDARY Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- All adults >=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery
- All adult (>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery
Exclusion Criteria
- Children and minors
- Pregnant women
- Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
- Patients with secondary or tertiary hyperparathyroidism
Data sourced from ClinicalTrials.gov (NCT05152927). 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. Informational only — not medical advice.