EUCTR2019-003506-26-ESActive, not recruitingPhase 1
Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
Hospital Universitari Son Espases0 sites40 target enrollmentStarted: January 14, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection.
- •Visualization of 2 or more parathyroid glands during the surgical act.
- •Normal renal and hepatic functions.
- •Absence of a history of hypersensitivity reactions to iodine or indocyanine
- •Able to understand the nature and protocol of the study and its procedures
- •Willingness to participate with the subsequent signing of informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
- •Age <18 years
- •Hepatic or renal insufficiency
- •Hypersensitivity to iodine or to indocyanine green.
- •Pregnancy or lactation
- •Inability to understand the nature and procedures of the study. • Patients with known preoperative hyperparathyroidism.
Investigators
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