An interventional study of BK 5000 Ultrasound Machine in Thyroid, Thyroid Cancer and Thyroid Diseases, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Diagnostic
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.
365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.
This study's planned enrollment of 17 is below the median of 88 across 198 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients set for total thyroidectomy incl. functional total thyroidectomies.
Device: BK 5000 Ultrasound Machine
Both 2D and 3D ultrasound is being used. 3D using optical tracking.
Thyroid volume
Obtaining thyroid volume with 2D ultrasound (length x Width x depth\*(Pi/6)) and 3D ultrasound with optical tracking and comparing the respective methods with a reference volume. Water displacement being gold standard for reference volume.
Time frame: 1 hour
Shrinkage in gland after excision
Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound
Time frame: 30 minutes
Interobserver variability
Variation in volume estimation when delineating ultrasound images.
Time frame: 2 hours
Plan to share: Undecided
Started May 2022 (actual). Primary completion is estimated for Oct 2022, 4 months after the start.
Of 73 non-industry interventional studies with no phase under Thyroid Diseases, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 57. This study's planned 4 months is below that.
Counting every sponsor, half of 74 studies reached it within 19 months; a quarter within 8 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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