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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03395925

Enrollment

Registered

2018-01-10

Start date

2017-11-10

Completion date

2022-01-30

Last updated

2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

Keywords

Thyroid Nodule, Bipolar coagulation electrode, radiofrequency ablation

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.

Interventions

DEVICECelon Pro Surge

bipolar coagulation electrode intended for tissue heating

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026