- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03395925
Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid
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.
Study Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Frankfurt, Germany, 60590
- Johann-Wolfgang Goethe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Celon Pro Surge
Ablation of thyroid tissue
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bipolar coagulation electrode intended for tissue heating
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Hüdayi Korkusuz, Prof., Goethe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEL THYRO01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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