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Trial record 11 of 1665 for:    ( Map: Bulgaria )

Treatment of Benign Thyroid Nodules With FastScan HIFU

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ClinicalTrials.gov Identifier: NCT02491502
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Theraclion

Brief Summary:
This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.

Condition or disease Intervention/treatment Phase
Benign Thyroid Nodules Device: Echopulse Not Applicable

Detailed Description:

Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)
Study Start Date : June 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Echopulse
Echopulse HIFU
Device: Echopulse
HIFU Under ultrasound guidance
Other Name: Echopulse HIFU



Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 1 day post treatment ]
  2. Number of participants with adverse events [ Time Frame: 3 days post treatment ]
  3. Number of participants with adverse events [ Time Frame: 7 days post treatment ]
  4. Change in volume of the thyroid nodule compared to Baseline at 6 months [ Time Frame: 6 months post treatment ]
  5. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day [ Time Frame: 1 day post treatment ]
  6. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days [ Time Frame: 3 days post treatment ]
  7. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days [ Time Frame: 7 days post treatment ]
  8. Patient satisfaction questionnaire [ Time Frame: 6 months post treatment ]

Secondary Outcome Measures :
  1. Number of patients with Absence of palpable lesion [ Time Frame: 3 months post treatment ]
  2. Number of patients with Absence of palpable lesion [ Time Frame: 6 months post treatment ]
  3. Patient Cosmetic evaluation measured by questionnaire [ Time Frame: 6 months post treatment ]
  4. Investigator rated evaluation of the device [ Time Frame: Post treatment Day 0 ]
  5. Change from Baseline of gland vascularization at 3 months [ Time Frame: 3 months post treatment ]
  6. Change from Baseline of gland vascularization at 6 months [ Time Frame: 6 months post treatment ]


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

Inclusion Criteria:

  • Male or female patient 18 years or older.
  • Patient presenting with at least one thyroid nodule with no signs of malignancy:

    1. Non suspect clinically and at ultrasonography imaging
    2. Benign cytological diagnosis at FNAB (fine-needle aspiration biopsy) from the last 6 months
    3. Normal serum calcitonin
    4. No history of neck irradiation
  • Normal TSH (thyroid-stimulating hormone)
  • Targeted nodule accessible and eligible to HIFU
  • Absence of abnormal vocal cord mobility at laryngoscopy
  • Nodule diameter ≥ 10mm measured by ultrasound
  • Composition of the targeted nodule(s) : predominantly solid
  • Patient has signed a written informed consent.

Exclusion Criteria:

  • Head and/or neck disease that prevents hyperextension of neck
  • Known history of thyroid cancer or other neoplasias in the neck region
  • History of neck irradiation
  • Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
  • Posterior position of the nodule if the thickness of the nodule is <15mm
  • Pregnant or lactating woman
  • Any contraindication to the assigned analgesia/anaesthesia.

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): NCT02491502


Contacts
Contact: Roussanka Kovatcheva, Prof. roussanka_kov@yahoo.com

Locations
Bulgaria
University Hospital of Endocrinology USBALE Recruiting
Sofia, Bulgaria, 1431
Contact: Roussanka Kovatcheva, Prof.         
Sponsors and Collaborators
Theraclion
Investigators
Principal Investigator: Roussanka Kovatcheva, Prof. roussanka_kov@yahoo.com

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT02491502     History of Changes
Other Study ID Numbers: HIFU/BG/TN/FS/2015
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms