An interventional study of Echopulse in Benign Thyroid Nodules, sponsored by Theraclion. Completed at 1 site in Bulgaria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by Theraclion · Not applicable, Interventional, and Treatment
This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.
Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.
In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's enrollment of 36 is below the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Theraclion is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient presenting with at least one thyroid nodule with no signs of :
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Echopulse HIFU
Device: Echopulse
HIFU Under ultrasound guidance
Also known as: Echopulse HIFU
Number of participants with adverse events
Time frame: 1 day post treatment
Number of participants with adverse events
Time frame: 3 days post treatment
Number of participants with adverse events
Time frame: 7 days post treatment
Change in volume of the thyroid nodule compared to Baseline at 6 months
Time frame: 6 months post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
Time frame: 1 day post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
Time frame: 3 days post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
Time frame: 7 days post treatment
Patient satisfaction questionnaire
Time frame: 6 months post treatment
Number of patients with Absence of palpable lesion
Time frame: 3 months post treatment
Number of patients with Absence of palpable lesion
Time frame: 6 months post treatment
Patient Cosmetic evaluation measured by questionnaire
Time frame: 6 months post treatment
Investigator rated evaluation of the device
Time frame: Post treatment Day 0
Change from Baseline of gland vascularization at 3 months
Time frame: 3 months post treatment
Change from Baseline of gland vascularization at 6 months
Time frame: 6 months post treatment
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Theraclion