TriangleNCT05022667 · REGISTRY CONDITION SEARCH
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
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
- 2025-08-08
This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
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
The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery
Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery
Blood Calcium Levels 24-48 Hours After Surgery
Duration in Minutes of Surgery
Number of Frozen Section Analysis Performed.
Number of Auto-transplanted Parathyroid Glands
Number of Nights Spent in the Hospital After Total Thyroidectomy
Number of Inadvertently Resected Parathyroid Glands
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland). * Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy. Exclusion Criteria: * Pregnant women * Patients with concurrent parathyroid and thyroid disease * Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure. * Patients undergoing thyroid lobectomy or partial thyroidectomy
- 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 total thyroidectomy procedure.
- intervention Names
- Device: PTeye
- label
- PTeye
- type
- EXPERIMENTAL
- description
- The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- label
- Standard of Care
- type
- NO_INTERVENTION
- 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, as per device functionality requirements.
- name
- PTeye
- type
- DEVICE
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- SINGLE
- who Masked
- PARTICIPANT
- primary Purpose
- PREVENTION
Enrollment
- count
- 114
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
- measure
- The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
- time Frame
- Immediate (During total thyroidectomy procedure)
- secondary Outcomes
- description
- Blood parathyroid hormone (PTH) levels at 5-14 days post-op
- measure
- Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery
- time Frame
- 5-14 days after surgery
- description
- Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery
- measure
- Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery
- time Frame
- Within 24-48 hours after surgery
- description
- Blood calcium levels 24-48 hours after surgery
- measure
- Blood Calcium Levels 24-48 Hours After Surgery
- time Frame
- Within 24-48 hours after surgery
- description
- Duration of surgery (minutes)
- measure
- Duration in Minutes of Surgery
- time Frame
- Collected immediately following surgery
- description
- Number of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.
- measure
- Number of Frozen Section Analysis Performed.
- time Frame
- Collected immediately following surgery
- description
- Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
- measure
- Number of Auto-transplanted Parathyroid Glands
- time Frame
- Immediate. During total thyroidectomy procedure
- description
- Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
- measure
- Number of Nights Spent in the Hospital After Total Thyroidectomy
- time Frame
- 0 - 4 nights after total thyroidectomy
- description
- Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. Results reflect the participants who had an inadvertently resected parathyroid gland.
- measure
- Number of Inadvertently Resected Parathyroid Glands
- time Frame
- Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)
Full study description
- brief Summary
- This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
- 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
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
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- offset unit
- unicode_code_points
- query cond
- Parathyroid Cancer
- query disease state id
- ds-parathyroid-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-parathyroid-cancer-000.json
- source file sha256
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Preserved source evidence · Not medical advice