Status:
COMPLETED
Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy.
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Postoperative Hypoparathyroidism
Thyroid Neoplasms
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
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 devic...
Detailed Description
Inadvertent damage or excision of a healthy parathyroid gland (PG) following a total thyroidectomy (TTx) could result in transient hypocalcemia (\< 6 months) in 5 - 35% of cases or permanent hypocalce...
Eligibility Criteria
Inclusion
- (i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).
- (ii) All patients undergoing completion thyroidectomy.
Exclusion
- (i) Patients with concurrent parathyroid disease. (ii) Patients with incidental enlarged parathyroid discovered during TTx. (iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.
Key Trial Info
Start Date :
March 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04281875
Start Date
March 16 2020
End Date
February 23 2024
Last Update
October 17 2024
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212