Clinical trial · Interventional
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
NCT04299425CI-TRIAL-00077080NIRAFcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 parathyroidectomy (PTx) procedures. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypercalcemia | — | UNRESOLVED | — |
| Parathyroid Adenoma | — | UNRESOLVED | — |
| Parathyroid Cancer | Parathyroid Cancer | ONTOLOGY_EXACT | 0.90 |
| Parathyroid Hyperplasia | — | UNRESOLVED | — |
| Parathyroid Neoplasms | Parathyroid Gland Neoplasm | ALIAS | 0.90 |
| Primary Hyperparathyroidism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NIRAF Detection Technology | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NIRAF Detection Technology +
- description
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).
- interventionNames
- Device: NIRAF Detection Technology
- type
- NO_INTERVENTION
- label
- NIRAF Detection Technology -
- description
- Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
Primary outcomes (1)
- measure
- Average Number of Parathyroid Glands Identified With High Confidence Per Patient
- timeFrame
- Immediate. During PTx procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * All primary hyperparathyroidism patients eligible for parathyroidectomy (PTx). Both bilateral and focused mode of PTx will be considered for this study, based on the surgeon's preference. * Re-operative primary hyperparathyroidism patients who have undergone a failed prior PTx. Exclusion Criteria: * Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy. * Patients with secondary or tertiary hyperparathyroidism.
References
Publications (13)
- BACKGROUNDSimental A, Ferris RL. Reoperative parathyroidectomy. Otolaryngol Clin North Am. 2008 Dec;41(6):1269-74, xii. doi: 10.1016/j.otc.2008.05.008. PMID 19040985
- BACKGROUNDCron DC, Kapeles SR, Andraska EA, Kwon ST, Kirk PS, McNeish BL, Lee CS, Hughes DT. Predictors of operative failure in parathyroidectomy for primary hyperparathyroidism. Am J Surg. 2017 Sep;214(3):509-514. doi: 10.1016/j.amjsurg.2017.01.012. Epub 2017 Jan 10. PMID 28108069
- BACKGROUNDDoherty GM, Weber B, Norton JA. Cost of unsuccessful surgery for primary hyperparathyroidism. Surgery. 1994 Dec;116(6):954-7; discussion 957-8. PMID 7985102
- BACKGROUNDWachtel H, Cerullo I, Bartlett EK, Kelz RR, Karakousis GC, Fraker DL. What Can We Learn from Intraoperative Parathyroid Hormone Levels that Do Not Drop Appropriately? Ann Surg Oncol. 2015;22(6):1781-8. doi: 10.1245/s10434-014-4201-9. Epub 2014 Oct 30. PMID 25354574
- BACKGROUNDMohebati A, Shaha AR. Imaging techniques in parathyroid surgery for primary hyperparathyroidism. Am J Otolaryngol. 2012 Jul-Aug;33(4):457-68. doi: 10.1016/j.amjoto.2011.10.010. Epub 2011 Dec 7. PMID 22154018
- BACKGROUNDAhuja AT, Wong KT, Ching AS, Fung MK, Lau JY, Yuen EH, King AD. Imaging for primary hyperparathyroidism--what beginners should know. Clin Radiol. 2004 Nov;59(11):967-76. doi: 10.1016/j.crad.2004.04.005. PMID 15488844
- BACKGROUNDSosa JA, Powe NR, Levine MA, Udelsman R, Zeiger MA. Profile of a clinical practice: Thresholds for surgery and surgical outcomes for patients with primary hyperparathyroidism: a national survey of endocrine surgeons. J Clin Endocrinol Metab. 1998 Aug;83(8):2658-65. doi: 10.1210/jcem.83.8.5006. PMID 9709928
- Chen H, Wang TS, Yen TW, Doffek K, Krzywda E, Schaefer S, Sippel RS, Wilson SD. Operative failures after parathyroidectomy for hyperparathyroidism: the influence of surgical volume. Ann Surg. 2010 Oct;252(4):691-5. doi: 10.1097/SLA.0b013e3181f698df.