Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules (NCT03646383) | Clinical Trial Compass
CompletedNot Applicable
Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules
France40 participantsStarted 2019-01-29
Plain-language summary
The purpose of the present protocol is to evaluate the response rate to treatment of these symptomatic benign nodules with radiofrequency as an alternative to surgical treatment.
This thyroid nodules ablation with radiofrequency will be directed by a single percutaneous procedure guided by ultrasound. The procedure includes an ultrasound with percutaneously radiofrequency ablation of benign thyroid nodule. Clinical and ultrasonographic monitoring will last a year with consultations at 2 weeks (consultation only), 3 months, 6 months and 1 year (consultation, ultrasound TSH). The success of this procedure will be controlled with 3 successive ultrasounds the following year. The expected results are a decrease in the size of the nodule by at least 50% and a reduction in the functional and aesthetic discomfort, with less frequent complication than what is expected with surgery. The present study also intends to determine the medico economic impact of this technique compared to surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Euthyroid or hypothyroidism properly substituted with normal TSH
* Benin nodule proved by FNA (Bethesda) and normal Calcitonin
* Nodule size\> 1cm and / or increase in size
* Single nodule or asymptomatic nodules associated
* Symptomatic nodule with functional impairment and / or aesthetic Patient Agreement
* Patient with insurance coverage
* Written agreement for participation
Exclusion Criteria:
The exclusion criteria are related to the histological nature of the nodule and the necessary of the procedure:
* Allergy to local anesthetics
* FNA non-contributory or suspicious nodule (Bethesda)
* Multiple nodules more than 2cm
* Hyperthyroidism or hyperparathyroidism associated requiring surgical intervention.
* Taking a treatment with anticoagulant or double antiplatelet
* Patient with a Pacemaker
* Contralateral laryngeal paralysis in nodule
* Purely cystic nodule
* Nodule in contact with the recurrent nerve
* Patient Refusal
* Pregnant and breastfeeding women
* Patient trust, guardianship or safeguard justice.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.