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

NCT03395925 | Withdrawn

• 1 other identifier: CEL THYRO01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule

Keywords

Thyroid Nodule; Bipolar coagulation electrode; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

Celon Pro Surge

EXPERIMENTAL

Ablation of thyroid tissue

Device: Celon Pro Surge

Interventions

Celon Pro Surge DEVICE

bipolar coagulation electrode intended for tissue heating

Also known as: Bipolar coagulation electrode, tissue heating and ablation

Celon Pro Surge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Malign nodules
• Pregnancy
• Pacemaker near the target issue (\<4cm)
• Nerve stimulating device
• High fever
• Prosthesis for the inner ear

Sponsors & Collaborators

• Olympus Surgical Technologies Europe: lead

Study Sites (1)

Johann-Wolfgang Goethe University

Frankfurt, 60590, Germany

Location

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Hüdayi Korkusuz, Prof.

  Goethe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: January 10, 2018
• Study Start: November 10, 2017
• Primary Completion: October 30, 2021
• Study Completion: January 30, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)