N/A N=80 Randomized Single-blind Prevention

Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy

Postoperative Hypoparathyroidism · Thyroid Disease · Thyroid Neoplasms · Thyroid Cancer

Bottom Line

View on ClinicalTrials.gov: NCT05579782 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Subjects With Transient Hypoparathyroidism. — 10; 14 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NIRAF Detection Technology (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical College of Wisconsin
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjects With Transient Hypoparathyroidism.	10; 14	—
PRIMARY Patients With Hypoparathyroidism at Last Follow-up	1; 1	—
SECONDARY Overall Average Number of Parathyroid Glands Identified With High Confidence.	3.4; 2.9	—
SECONDARY Number of Participants With Frozen Sections Sent for Analysis.	38; 30; 1; 11	—
SECONDARY Number of Participants With Auto-transplanted Parathyroid Glands	31; 31; 7; 8; 1; 2	—
SECONDARY Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy	0; 1; 39; 38; 0; 2	—
SECONDARY Number of Participants With Inadvertently Resected Parathyroid Glands	9; 8	—
SECONDARY Number of Doctor Visits/Emergency Department Visits or Hospital Admissions	0; 0	—
SECONDARY Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery	—	—

Summary

This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Eligibility Criteria

Inclusion Criteria

(i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).

(ii) All patients undergoing completion thyroidectomy.

Exclusion Criteria

(i) Patients with concurrent parathyroid disease.

(ii) Patients with incidental enlarged parathyroid discovered during TTx.

(iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05579782). 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.