Back to results

Treatment of Benign Thyroid Nodules With FastScan HIFU

Primary Purpose

Benign Thyroid Nodules

Status

Completed

Phase

Not Applicable

Locations

Bulgaria

Study Type

Interventional

Intervention

Echopulse

About this trial

This is an interventional treatment trial for Benign Thyroid Nodules

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital of Endocrinology USBALE

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echopulse

Arm Description

Echopulse HIFU

Outcomes

Primary Outcome Measures

Number of participants with adverse events

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

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

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

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

Patient satisfaction questionnaire

Secondary Outcome Measures

Number of patients with Absence of palpable lesion

Patient Cosmetic evaluation measured by questionnaire

Investigator rated evaluation of the device

Change from Baseline of gland vascularization at 3 months

Change from Baseline of gland vascularization at 6 months

Full Information

NCT ID

NCT02491502

First Posted

June 24, 2015

Last Updated

October 11, 2021

Sponsor

Theraclion

1. Study Identification

Unique Protocol Identification Number

NCT02491502

Brief Title

Treatment of Benign Thyroid Nodules With FastScan HIFU

Official Title

Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

April 2020 (Actual)

Study Completion Date

July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theraclion

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Thyroid Nodules

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Echopulse

Arm Type

Experimental

Arm Description

Echopulse HIFU

Intervention Type

Device

Intervention Name(s)

Echopulse

Other Intervention Name(s)

Echopulse HIFU

Intervention Description

HIFU Under ultrasound guidance

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

1 day post treatment

Title

Number of participants with adverse events

Time Frame

3 days post treatment

Title

Number of participants with adverse events

Time Frame

7 days post treatment

Title

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

Time Frame

6 months post treatment

Title

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

Time Frame

1 day post treatment

Title

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

Time Frame

3 days post treatment

Title

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

Time Frame

7 days post treatment

Title

Patient satisfaction questionnaire

Time Frame

6 months post treatment

Secondary Outcome Measure Information:

Title

Number of patients with Absence of palpable lesion

Time Frame

3 months post treatment

Title

Number of patients with Absence of palpable lesion

Time Frame

6 months post treatment

Title

Patient Cosmetic evaluation measured by questionnaire

Time Frame

6 months post treatment

Title

Investigator rated evaluation of the device

Time Frame

Post treatment Day 0

Title

Change from Baseline of gland vascularization at 3 months

Time Frame

3 months post treatment

Title

Change from Baseline of gland vascularization at 6 months

Time Frame

6 months post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roussanka Kovatcheva, Prof.

Organizational Affiliation

roussanka_kov@yahoo.com

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Endocrinology USBALE

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

12. IPD Sharing Statement

Learn more about this trial

Treatment of Benign Thyroid Nodules With FastScan HIFU

We'll reach out to this number within 24 hrs