N/A N=160 Randomized Single-blind Prevention

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

Postoperative Hypoparathyroidism · Thyroid Neoplasms · Thyroid Cancer

Bottom Line

View on ClinicalTrials.gov: NCT04281875 ↗

Enrolled (actual)

160

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Average Number of Parathyroid Glands Identified With High Confidence Per Patient — 2.81; 2.75 parathyroid glands — p=0.6905

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NIRAF Detection Technology (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt-Ingram Cancer Center
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Number of Parathyroid Glands Identified With High Confidence Per Patient	2.81; 2.75	0.6905
SECONDARY Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)	0; 0	—
SECONDARY Postoperative Hypoparathyroidism/Hypocalcemia (Transient)	3; 5	—
SECONDARY Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)	19; 16	—
SECONDARY Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).	0.08; 0.1	—
SECONDARY Number of Auto-transplanted Parathyroid Glands	43; 39	—
SECONDARY Number of Nights Spent in the Hospital After Total Thyroidectomy	1; 4; 77; 72; 2; 4	—
SECONDARY Number of Inadvertently Resected Parathyroid Glands	0.09; 0.06	—

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 (PGs) during total thyroidectomy (TTx). It compares risk-benefits and outcomes in TTx patients 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 (NCT04281875). 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.