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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celon Pro Surge | Experimental | Ablation of thyroid tissue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celon Pro Surge | Device | bipolar coagulation electrode intended for tissue heating |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hüdayi Korkusuz, Prof. | Goethe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johann-Wolfgang Goethe University | Frankfurt | 60590 | Germany |
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| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |