Clinical trial · Observational
Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study
- 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)
The goal of this observational study is to evaluate the efficacy of PTeyeTM device to confirm a parathyroid adenoma on a visually suspected tissue in comparison with the FLUOBEAM®LX device. The main questions it aims to answer is: Is the PTeyeTM device effective in identifying the presence of a parathyroid adenoma? Which autofluorecence device (PTeye or FLUOBEAM®LX) is more effective in confirming the presence of a parathyroid adenoma? Participants will undergo parathyroidectomy under general anesthesia. During the procedure visually suspected tissue for parathyroid adenoma will be evaluated with the PTeye or FLUOBEAM®LX device for the presence of an adenoma (minute 0). Tissue will be reevaluated on minutes 1, 3, and 5 and before excision.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Hyperparathyroidism Due to Adenoma | Parathyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parathyroidectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PTeye
- description
- Localizing Parathyroid adenoma with the PTeye device during parathyroidectomy
- interventionNames
- Device: Parathyroidectomy
- label
- Fluobeam
- description
- Localizing Parathyroid adenoma with the Fluobeam/ Fluoptics device
- interventionNames
- Device: Parathyroidectomy
Primary outcomes (1)
- measure
- Identification of the parathyroid adenoma
- timeFrame
- The minute of the identification of the parathyroid adenoma (minute 0). Reevaluation in minutes 1, 3, and 5 during tissue dissection and before excision.
- description
- The percentage of adenomas identified by each device is assessed after intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0). The same percentage will be re-evaluated on minutes 1, 3 and 5 during tissue dissection and before adenoma excision.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: \- Patients with Primary parathyroidism with parathyroid adenoma Exclusion Criteria: * Parathyroid Hyperplasia, * Secondary hyperparathyroidism
References
Publications (0)
Data not yet available