Adults 18 to 99, any sex, with Postoperative Hypoparathyroidism or Thyroid Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Average Number of Parathyroid Glands Identified With High Confidence Per PatientPrimary· Immediate. During total thyroidectomy procedure.
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
Group
Value
95% CI
NIRAF Detection Technology +
2.81
± 1.03
NIRAF Detection Technology -
2.75
± 0.95
Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)Secondary· 6 months after total thyroidectomy
If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level and/or PTH is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if PTH \< 16 pg/mL and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.
Group
Value
95% CI
NIRAF Detection Technology +
0
NIRAF Detection Technology -
0
Postoperative Hypoparathyroidism/Hypocalcemia (Transient)Secondary· 5 days to 6 months after total thyroidectomy.
Undetectable postoperative PTH and/or low calcium (total calcium \< 2mmol/L or 8 mg/dL, serum intact PTH \< 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-30 days after total thyroidectomy).
Group
Value
95% CI
NIRAF Detection Technology +
3
NIRAF Detection Technology -
5
Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)Secondary· Within 24 hours after total thyroidectomy.
Postoperative low calcium (total calcium \<8mg/dL or \<2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH \< 16 pg/mL or 1 pmol/L) within 24 hours after surgery
Group
Value
95% CI
NIRAF Detection Technology +
19
NIRAF Detection Technology -
16
Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).Secondary· Immediate. During total thyroidectomy procedure.
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Group
Value
95% CI
NIRAF Detection Technology +
0.08
± 0.4
NIRAF Detection Technology -
0.1
± 0.3
Number of Auto-transplanted Parathyroid GlandsSecondary· Immediate. During total thyroidectomy procedure.
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Group
Value
95% CI
NIRAF Detection Technology +
43
NIRAF Detection Technology -
39
Number of Nights Spent in the Hospital After Total ThyroidectomySecondary· 0 - 4 nights after total thyroidectomy
Number of nights spent in the hospital after the surgical procedure. 0 nights, 1 night, \>1 night
Group
Value
95% CI
NIRAF Detection Technology +
1
NIRAF Detection Technology -
4
NIRAF Detection Technology +
77
NIRAF Detection Technology -
72
NIRAF Detection Technology +
2
NIRAF Detection Technology -
4
Number of Inadvertently Resected Parathyroid GlandsSecondary· Intraoperatively or on histology (within 24 hours post operation)
Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
Group
Value
95% CI
NIRAF Detection Technology +
0.09
± 0.3
NIRAF Detection Technology -
0.06
± 0.2
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center
Last refreshed: 17 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04281875.