Status:
COMPLETED
Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Haukeland University Hospital
Jagiellonian University
Conditions:
Hypoparathyroidism Postprocedural
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathy...
Detailed Description
Temporary and permanent hypoparathyroidism is probably the most important complication of total thyroidectomy. The rate of permanent hypoparathyroidism in quality registries are in the range of is 5-7...
Eligibility Criteria
Inclusion
- Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis
Exclusion
- Previous thyroid surgery
- Previous parathyroid surgery
- Concurrent parathyroid surgery
- Renal insufficiency
- Pregnancy
- Breast feeding
- Allergy (contrast agent, iodine)
- Inability to understand study information
- Patient unable to participate in planned follow-up program
Key Trial Info
Start Date :
January 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT04509011
Start Date
January 5 2021
End Date
July 31 2023
Last Update
November 15 2024
Active Locations (5)
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1
Rudolfstiftung
Vienna, Austria, 1030
2
Haukeland University Hospital
Bergen, Norway, 5021
3
Jagiellonian University Medical College
Krakow, Poland, 31-008
4
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345