Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid

Study Overview
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Brief Summary
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Thyroid nodules are among the common alterations of the thyroid. Depending on the detection method the prevalence is between 20% and 50%, whereas the incidence increases with improvement of ultrasonic technology. The CelonPro Surge bipolar coagulation electrode operated with the compatible power control unit and compatible tube pump is indicated for ablation and coagulation of soft tissue, including thermal inactivation and/or volume reduction of locally defined tissue areas, such as tumors and metastases. The primary objective of the study is to assess the influence of radiofrequency ablation due to thyroid volume after 24 hours, 3 months, 6 months and 1 year.

Official Title
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Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Device: Celon Pro Surge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given written (personally signed and dated) informed consent before completing any study-related procedures (i.e. any assessment or evaluation that would not have formed part of their normal medical care). The patient must be aged 18yrs or older. The patient must be able to understand, and be willing to comply with the requirements of the protocol The patient is not pregnant The patient has the diagnosis of benign thyroid nodules, struma diffusa, struma uninodosa, struma multinodosa, struma per magna, Thyroidea nodosa or Thyroidea multinodosa The patient rejected surgery The patient rejected sole radioiodine therapy Exclusion Criteria: Malign nodules Pregnancy Pacemaker near the target issue (<4cm) Nerve stimulating device High fever Prosthesis for the inner ear

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celon Pro Surge<br>Ablation of thyroid tissue | Device: Celon Pro Surge<br>* bipolar coagulation electrode intended for tissue heating<br>* Other names: Bipolar coagulation electrode, tissue heating and ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue | The primary endpoint is the reduction of thyroid volume at 12-Month follow-up visit. A responder to the radiofrequency treatment is defined as a subject with any reduction of the thyroid volume. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid Nodule, Bipolar coagulation electrode, radiofrequency ablation