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

Primary Purpose

Thyroid Nodule

Status

Withdrawn

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Celon Pro Surge

About this trial

This is an interventional treatment trial for Thyroid Nodule focused on measuring Thyroid Nodule, Bipolar coagulation electrode, radiofrequency ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Johann-Wolfgang Goethe University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celon Pro Surge

Arm Description

Ablation of thyroid tissue

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03395925

First Posted

December 17, 2017

Last Updated

December 21, 2022

Sponsor

Olympus Surgical Technologies Europe

1. Study Identification

Unique Protocol Identification Number

NCT03395925

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Study was not started

Study Start Date

November 10, 2017 (Actual)

Primary Completion Date

October 30, 2021 (Anticipated)

Study Completion Date

January 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Olympus Surgical Technologies Europe

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Nodule

Keywords

Thyroid Nodule, Bipolar coagulation electrode, radiofrequency ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Celon Pro Surge

Arm Type

Experimental

Arm Description

Ablation of thyroid tissue

Intervention Type

Device

Intervention Name(s)

Celon Pro Surge

Other Intervention Name(s)

Bipolar coagulation electrode, tissue heating and ablation

Intervention Description

bipolar coagulation electrode intended for tissue heating

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hüdayi Korkusuz, Prof.

Organizational Affiliation

Goethe University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johann-Wolfgang Goethe University

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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