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Treatment of Benign Thyroid Nodules With FastScan HIFU

Sponsor
Theraclion (Industry)
Overall Status
Completed
CT.gov ID
NCT02491502
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
61
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Echopulse
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
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 :
Jun 1, 2015
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Echopulse

Echopulse HIFU

Device: Echopulse
HIFU Under ultrasound guidance
Other Names:
  • Echopulse HIFU

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events [1 day post treatment]

    2. Number of participants with adverse events [3 days post treatment]

    3. Number of participants with adverse events [7 days post treatment]

    4. Change in volume of the thyroid nodule compared to Baseline at 6 months [6 months post treatment]

    5. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day [1 day post treatment]

    6. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days [3 days post treatment]

    7. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days [7 days post treatment]

    8. Patient satisfaction questionnaire [6 months post treatment]

    Secondary Outcome Measures

    1. Number of patients with Absence of palpable lesion [3 months post treatment]

    2. Number of patients with Absence of palpable lesion [6 months post treatment]

    3. Patient Cosmetic evaluation measured by questionnaire [6 months post treatment]

    4. Investigator rated evaluation of the device [Post treatment Day 0]

    5. Change from Baseline of gland vascularization at 3 months [3 months post treatment]

    6. Change from Baseline of gland vascularization at 6 months [6 months post treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Endocrinology USBALE Sofia Bulgaria 1431

    Sponsors and Collaborators

    • Theraclion

    Investigators

    • Principal Investigator: Roussanka Kovatcheva, Prof., roussanka_kov@yahoo.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Theraclion
    ClinicalTrials.gov Identifier:
    NCT02491502
    Other Study ID Numbers:
    • HIFU/BG/TN/FS/2015
    First Posted:
    Jul 8, 2015
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Thyroid Nodule
    Thyroid Diseases

    Study Results

    No Results Posted as of Oct 12, 2021