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

NCT ID: NCT03395925

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2022-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Nodule

Keywords

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Thyroid Nodule Bipolar coagulation electrode radiofrequency ablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Celon Pro Surge

Ablation of thyroid tissue

Group Type EXPERIMENTAL

Celon Pro Surge

Intervention Type DEVICE

bipolar coagulation electrode intended for tissue heating

Interventions

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Celon Pro Surge

bipolar coagulation electrode intended for tissue heating

Intervention Type DEVICE

Other Intervention Names

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Bipolar coagulation electrode, tissue heating and ablation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olympus Surgical Technologies Europe

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hüdayi Korkusuz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

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Johann-Wolfgang Goethe University

Frankfurt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CEL THYRO01

Identifier Type: -

Identifier Source: org_study_id