Trials / Completed
CompletedNCT05022667
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Thyroid Neoplasms
- Thyroid Diseases
- Hypoparathyroidism
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Neoplasms by Site
- Neoplasms
- Head and Neck Neoplasms
- Parathyroid Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PTeye | 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. |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2024-05-31
- Completion
- 2024-05-31
- First posted
- 2021-08-26
- Last updated
- 2025-08-08
- Results posted
- 2025-08-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05022667. Inclusion in this directory is not an endorsement.