N/A
Completed N=114
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Source: ClinicalTrials.gov NCT05022667 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient — 3.1; 2.9 parathyroid glands per patient — p=0.3
Summary
This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient |
3.1; 2.9 | 0.3 |
| SECONDARY Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery |
35.6; 41 | .5 |
| SECONDARY Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery |
20.7; 24.3 | .2 |
| SECONDARY Blood Calcium Levels 24-48 Hours After Surgery |
9.4; 9.3 | 0.3 |
| SECONDARY Duration in Minutes of Surgery |
126.2; 120.3 | .4 |
| SECONDARY Number of Frozen Section Analysis Performed. |
55; 55; 2; 2 | — |
| SECONDARY Number of Auto-transplanted Parathyroid Glands |
41; 46; 16; 10; 0; 1 | .3 |
| SECONDARY Number of Nights Spent in the Hospital After Total Thyroidectomy |
0; 0; 57; 57; 0; 0 | — |
| SECONDARY Number of Inadvertently Resected Parathyroid Glands |
5; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).
- Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.
Exclusion Criteria
- Pregnant women
- Patients with concurrent parathyroid and thyroid disease
- Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure.
- Patients undergoing thyroid lobectomy or partial thyroidectomy
Data sourced from ClinicalTrials.gov (NCT05022667). 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.