Treatment of Benign Thyroid Nodules With FastScan HIFU

NCT02491502 | Completed

• 1 other identifier: HIFU/BG/TN/FS/2015
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Thyroid Nodules

Outcome Measures

Primary Outcomes (8)

• Number of participants with adverse events

  1 day post treatment

• Number of participants with adverse events

  3 days post treatment

• Number of participants with adverse events

  7 days post treatment

• Change in volume of the thyroid nodule compared to Baseline at 6 months

  6 months post treatment

• Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day

  1 day post treatment

• Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days

  3 days post treatment

• Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days

  7 days post treatment

• Patient satisfaction questionnaire

  6 months post treatment

Secondary Outcomes (6)

• Number of patients with Absence of palpable lesion

  3 months post treatment

• Number of patients with Absence of palpable lesion

  6 months post treatment

• Patient Cosmetic evaluation measured by questionnaire

  6 months post treatment

• Investigator rated evaluation of the device

  Post treatment Day 0

• Change from Baseline of gland vascularization at 3 months

  3 months post treatment

Study Arms (1)

Echopulse

EXPERIMENTAL

Echopulse HIFU

Device: Echopulse

Interventions

Echopulse DEVICE

HIFU Under ultrasound guidance

Also known as: Echopulse HIFU

Echopulse

Eligibility Criteria

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

You may qualify if:

• Male or female patient 18 years or older.
• Patient presenting with at least one thyroid nodule with no signs of malignancy:
• Non suspect clinically and at ultrasonography imaging
• Benign cytological diagnosis at FNAB (fine-needle aspiration biopsy) from the last 6 months
• Normal serum calcitonin
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theraclion: lead

Study Sites (1)

University Hospital of Endocrinology USBALE

Sofia, 1431, Bulgaria

Location

Study Officials

• Roussanka Kovatcheva, Prof.

  roussanka_kov@yahoo.com

  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: June 24, 2015
• First Posted: July 8, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

BU (1)