Non-malignant Thyroid NodulesNCT02258347
HIFU in Patients With Non-malignant Thyroid Nodules
A study testing Echopulse in people with Non-malignant Thyroid Nodules, run by Theraclion at 1 site in Italy.
Trial summary
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-malignant 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
- 4 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2014to 13 Oct 2015
- 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 fine-needle aspiration biopsy (FNAB) from the last 6 months
- Normal serum calcitonin
- No history of neck irradiation
Show all 12Show fewer
- Normal thyroid-stimulating hormone (TSH).
- Targeted nodule accessible and eligible to HIFU
- Absence of abnormal vocal cord mobility at laryngoscopy.
- Nodule diameter ≥ 10mm measured by ultrasound.
- Nodule volume inferior to 10 cc
- Composition of the targeted nodule(s) : no more than 30% cystic
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.
Italy1 site
Istituto in tecnologie avanzate e modelli assistenziali in oncologia
Reggio Emilia, 42100
About this study
Official title: Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
- Conditions
- Non-malignant 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
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Device: Echopulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)
Measured: Month 6 and Month 12
Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
Measured: Month 6 and Month 12
Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)
Measured: Month 6 and Month 12
Secondary outcomes (1)
Number of subjects with adverse events as a measure of safety and tolerability
Measured: Day 1, Month 1, Month 3, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startJul 2014
- Primary completion13 Oct 2015
- Study completion13 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-malignant 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Frasoldati, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258347
- Sponsor's protocol ID
- HIFU/REG/NT
- Status last verified
- May 2018
- First submitted
- 26 Sep 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
- ClinicalTrials.gov ID
- NCT02258347
- Acronym / sponsor ID
- HIFU/REG/NT
- Conditions
- Non-malignant Thyroid Nodules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- 13 Oct 2015 (actual)
- Study completion
- 13 Oct 2015 (actual)
- First posted
- 7 Oct 2014 (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.
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Echopulse |
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 thyroid-stimulating hormone (TSH).
- 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 |
|---|---|---|
| Echopulse | Device | Single arm |
Primary outcome
Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)
Time frame: Month 6 and Month 12
Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
Time frame: Month 6 and Month 12
Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)
Time frame: Month 6 and Month 12
1 secondary outcome
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: Day 1, Month 1, Month 3, Month 6 and Month 12
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 28 Aug 2019.
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.
Andrea Frasoldati, Dr principal investigator
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 Non-malignant Thyroid Nodules, run by Theraclion at 1 site in Italy.
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 28 Aug 2019. 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 Italy. 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?
Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US) (time frame: Month 6 and Month 12). The study lists 3 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 28 Aug 2019.