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Trial Title:
Three-dimensional Ultrasonography Thyroid Volume Measurement.
NCT ID:
NCT05510609
Condition:
Thyroid
Thyroid Cancer
Thyroid Diseases
Graves Disease
Thyroid Goiter
Thyroid Adenoma
Conditions: Official terms:
Thyroid Neoplasms
Adenoma
Graves Disease
Thyroid Diseases
Goiter
Conditions: Keywords:
Ultrasound
Ultrasonography
Volumetry
Thyroid Gland
Three Dimensional
3D
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
BK 5000 Ultrasound Machine
Description:
Both 2D and 3D ultrasound is being used. 3D using optical tracking.
Arm group label:
Thyroidectomy
Summary:
The purpose of this clinical trial is to investigate the accuracy of applying
three-dimensional ultrasound on thyroid gland patients when determining a gland volume.
The method will be compared to conventional b-mode ultrasound where three axis
measurements (length, width, and depth) are evaluated in the ellipsoid model.
The three dimensional (3D) method is utilizing optical tracking connected to the
ultrasound image to form cross-sectional imaging. Patients enrolled in the study are set
for complete thyroidectomies enabling a true volume of the gland by water displacement
after excision.
The aim is to find if this 3D method is more accurate in volume estimation than the
ellipsoid model.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients referred to Rigshospitalet to undergo a complete thyroidectomy including
patients with previous hemithyroidectomy
- Adults, 18 or older.
- Ability to give written informed consent
Exclusion Criteria:
- Thyroid glands that are too enlarged causing visualization/measurement impairment
with ultrasonography.
- Thyroid cancer with preoperative suspected extracapsular spread.
- Thyroids or lymph nodes that need frozen section examination.
Gender:
All
Minimum age:
18 Years
Maximum age:
110 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Tobias Todsen, MD, PhD, associate professor
Phone:
+4535452071
Email:
tobias.todsen@regionh.dk
Start date:
May 9, 2022
Completion date:
November 1, 2022
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05510609
