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

Not Applicable

Withdrawn

• Conditions: Thyroid Nodule
• Interventions: Device: Celon Pro Surge

• Registration Number: NCT03395925
• Lead Sponsor: Olympus Surgical Technologies Europe

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-10
• Study First Submitted: 2017-12-17
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Primary Completion: 2021-10-30
• Study Completion: 2022-01-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Celon Pro Surge	Celon Pro Surge	Ablation of thyroid tissue

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue	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.

Trial Locations

Locations (1)

Johann-Wolfgang Goethe University; 🇩🇪 Frankfurt, Germany