Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid
|ClinicalTrials.gov Identifier: NCT03395925|
Recruitment Status : Unknown
Verified January 2018 by Olympus Surgical Technologies Europe.
Recruitment status was: Recruiting
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Nodule||Device: Celon Pro Surge||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid|
|Actual Study Start Date :||November 10, 2017|
|Estimated Primary Completion Date :||October 30, 2018|
|Estimated Study Completion Date :||January 30, 2019|
Experimental: Celon Pro Surge
Ablation of thyroid tissue
Device: Celon Pro Surge
bipolar coagulation electrode intended for tissue heating
Other Name: Bipolar coagulation electrode, tissue heating and ablation
- The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue [ Time Frame: 1 year ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395925
|Contact: Hüdayi Korkusuz, Prof.||+49 69 / 6301 - email@example.com|
|Johann-Wolfgang Goethe University||Recruiting|
|Frankfurt, Germany, 60590|
|Contact: Hüdayi Korkusuz, Prof. +49 69 / 6301 - 6783 firstname.lastname@example.org|
|Principal Investigator:||Hüdayi Korkusuz, Prof.||Goethe University|