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

O

Olympus

Status

Withdrawn

Conditions

Thyroid Nodule

Treatments

Device: Celon Pro Surge

Study type

Interventional

Funder types

Industry

Identifiers

NCT03395925
CEL THYRO01

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Celon Pro Surge
Experimental group
Description:
Ablation of thyroid tissue
Treatment:
Device: Celon Pro Surge

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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