Benign Thyroid NodulesNCT02491502
Treatment of Benign Thyroid Nodules With FastScan HIFU
A study testing Echopulse in people with Benign Thyroid Nodules, run by Theraclion at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Thyroid Nodules
- What is being tested?
- Echopulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBulgaria
- Study dates
- Jun 2015to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)
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.
Read the 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.
- Conditions
- Benign Thyroid Nodules
- Being tested
- Echopulse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchopulseDevice
Also called Echopulse HIFU
HIFU Under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Echopulse | Experimental | Echopulse HIFU Receives: Device: Echopulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 1 day post treatment
Number of participants with adverse events
Measured: 3 days post treatment
Number of participants with adverse events
Measured: 7 days post treatment
Change in volume of the thyroid nodule compared to Baseline at 6 months
Measured: 6 months post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
Measured: 1 day post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
Measured: 3 days post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
Measured: 7 days post treatment
Patient satisfaction questionnaire
Measured: 6 months post treatment
Secondary outcomes (6)
Number of patients with Absence of palpable lesion
Measured: 3 months post treatment
Number of patients with Absence of palpable lesion
Measured: 6 months post treatment
Patient Cosmetic evaluation measured by questionnaire
Measured: 6 months post treatment
Investigator rated evaluation of the device
Measured: Post treatment Day 0
Change from Baseline of gland vascularization at 3 months
Measured: 3 months post treatment
Change from Baseline of gland vascularization at 6 months
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roussanka Kovatcheva, Prof., Principal investigator, roussanka_kov@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491502
- Sponsor's protocol ID
- HIFU/BG/TN/FS/2015
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2015
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Benign Thyroid Nodules With FastScan High Intensity Focused Ultrasound (HIFU)
- ClinicalTrials.gov ID
- NCT02491502
- Acronym / sponsor ID
- HIFU/BG/TN/FS/2015
- Conditions
- Benign Thyroid Nodules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Apr 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echopulse | Experimental | Device: EchopulseEchopulse HIFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patient 18 years or older.
- Patient presenting with at least one thyroid nodule with no signs of malignancy:
- Normal TSH (thyroid-stimulating hormone)
- Targeted nodule accessible and eligible to HIFU
- Absence of abnormal vocal cord mobility at laryngoscopy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchopulseAlso: Echopulse HIFUHIFU Under ultrasound guidance | Device | Echopulse |
Primary outcome
Number of participants with adverse events
Time frame: 1 day post treatment
Number of participants with adverse events
Time frame: 3 days post treatment
Number of participants with adverse events
Time frame: 7 days post treatment
Change in volume of the thyroid nodule compared to Baseline at 6 months
Time frame: 6 months post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day
Time frame: 1 day post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days
Time frame: 3 days post treatment
Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days
Time frame: 7 days post treatment
Patient satisfaction questionnaire
Time frame: 6 months post treatment
6 secondary outcomes
Number of patients with Absence of palpable lesion
Time frame: 3 months post treatment
Number of patients with Absence of palpable lesion
Time frame: 6 months post treatment
Patient Cosmetic evaluation measured by questionnaire
Time frame: 6 months post treatment
Investigator rated evaluation of the device
Time frame: Post treatment Day 0
Change from Baseline of gland vascularization at 3 months
Time frame: 3 months post treatment
Change from Baseline of gland vascularization at 6 months
Time frame: 6 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roussanka Kovatcheva, Prof. principal investigator
roussanka_kov@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echopulse in people with Benign Thyroid Nodules, run by Theraclion at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 1 day post treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.