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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03395925
• Other study ID #: CEL THYRO01
• Status: Withdrawn
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: January 30, 2022

Study information

• Verified date: December 2022
• Source: Olympus Surgical Technologies Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• Celon Pro Surge
bipolar coagulation electrode intended for tissue heating

Locations

Country	Name	City	State
Germany	Johann-Wolfgang Goethe University	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Surgical Technologies Europe

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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