TriangleNCT05022641 · REGISTRY CONDITION SEARCH
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2025-08-27
This study will see if 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 is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used. Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Average Number of Parathyroid Glands Identified
Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery
Appropriate Intraoperative Parathyroid Hormone Drop
Duration of Surgery
Number of Nights Spent in the Hospital After Parathyroidectomy
Number of Frozen Sections
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Primary hyperparathyroidism who will be undergoing parathyroid surgery * Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery Exclusion Criteria: * Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.) * Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy * Patients with secondary or tertiary hyperparathyroidism
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.
- intervention Names
- Device: PTeye
- label
- PTeye
- type
- EXPERIMENTAL
- description
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- intervention Names
- Other: Standard of Care
- label
- Standard of Care
- type
- OTHER
- interventions
- arm Group Labels
- PTeye
- description
- The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.
- name
- PTeye
- type
- DEVICE
- arm Group Labels
- Standard of Care
- description
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- name
- Standard of Care
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- SINGLE
- masking Description
- Only participants will be masked to the intervention
- who Masked
- PARTICIPANT
- primary Purpose
- PREVENTION
Enrollment
- count
- 160
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
- measure
- Average Number of Parathyroid Glands Identified
- time Frame
- Measured within the procedure, generally not more than 2 hours
- secondary Outcomes
- description
- Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.
- measure
- Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery
- time Frame
- 5-14 days after surgery
- description
- \>50% drop from baseline at 10 minutes post-resection
- measure
- Appropriate Intraoperative Parathyroid Hormone Drop
- time Frame
- baseline to 10 minutes
- description
- Surgery duration in minutes
- measure
- Duration of Surgery
- time Frame
- Measured within the procedure, generally not more than 2 hours
- description
- Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
- measure
- Number of Nights Spent in the Hospital After Parathyroidectomy
- time Frame
- 0-72 hours after PTx procedure.
- description
- Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.
- measure
- Number of Frozen Sections
- time Frame
- Immediate
Full study description
- brief Summary
- This study will see if 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 is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used. Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.
- detailed Description
- Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.
Source references
- references
- citation
- Cousart AG, Kiernan CM, Willmon PA, Thomas G, Wang TS, Gauger PG, Duh QY, Underwood HJ, Jackson A, Patel A, Mahadevan-Jansen A, Solorzano CC. Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):936-944. doi: 10.1001/jamasurg.2025.2233.
- pmid
- 40668552
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice