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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395925
Recruitment Status : Unknown
Verified January 2018 by Olympus Surgical Technologies Europe.
Recruitment status was:  Recruiting
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Thyroid Nodule Device: Celon Pro Surge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: Celon Pro Surge
Ablation of thyroid tissue
Device: Celon Pro Surge
bipolar coagulation electrode intended for tissue heating
Other Name: Bipolar coagulation electrode, tissue heating and ablation




Primary Outcome Measures :
  1. The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395925


Contacts
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Contact: Hüdayi Korkusuz, Prof. +49 69 / 6301 - 6783 huedayi.korkusuz@kgu.de

Locations
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Germany
Johann-Wolfgang Goethe University Recruiting
Frankfurt, Germany, 60590
Contact: Hüdayi Korkusuz, Prof.    +49 69 / 6301 - 6783    huedayi.korkusuz@kgu.de   
Sponsors and Collaborators
Olympus Surgical Technologies Europe
Investigators
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Principal Investigator: Hüdayi Korkusuz, Prof. Goethe University
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Responsible Party: Olympus Surgical Technologies Europe
ClinicalTrials.gov Identifier: NCT03395925    
Other Study ID Numbers: CEL THYRO01
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olympus Surgical Technologies Europe:
Thyroid Nodule
Bipolar coagulation electrode
radiofrequency ablation
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms