Breast FibroadenomaNCT01331954
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
A study testing Ultrasonic ablation device in people with Breast Fibroadenoma, run by Theraclion at 1 site in Bulgaria.
Trial summary
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Fibroadenoma
- What is being tested?
- Ultrasonic ablation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBulgaria
- Study dates
- Mar 2011to Sep 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One breast fibroadenoma with diagnosis based on:
- Clinical examination
- Ultrasound image
- For women older than 35 years: mammogram with BI-RADS score < 3
- Histologic confirmation by two independent readers
- Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound)
Who cannot join
- Patient pregnant or lactating
- Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion.
- History of breast cancer or history of laser or radiation therapy to the target breast
- Breast implants
- Breast cyst
- Fibroadenoma not clearly visible on the ultrasound images (in B mode)
- Patient participating in other trials using drugs or devices
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
Sofia, 1431
About this study
Official title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.
- Conditions
- Breast Fibroadenoma
- Being tested
- Ultrasonic ablation device
- Medical subject headings
- Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic ablation deviceDevice
Also called TH-One
One or two HIFU procedures
| Study group | Role | What they receive |
|---|---|---|
| HIFU | Experimental | Not described Receives: Device: Ultrasonic ablation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of breast fibroadenoma volume at ultrasonography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast FibroadenomaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roussanka Kovatcheva, M, Principal investigator, University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331954
- Sponsor's protocol ID
- HIFU/BG/FA/Jan2011
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2011
- Last updated
- 11 Apr 2024
- Results posted
- No
Publications
Kovatcheva R, Zaletel K, Vlahov J, Stoinov J. Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound. 2017 Mar 16;5:1. doi: 10.1186/s40349-017-0083-1. eCollection 2017.
PubMed 28331611
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
- ClinicalTrials.gov ID
- NCT01331954
- Acronym / sponsor ID
- HIFU/BG/FA/Jan2011
- Conditions
- Breast Fibroadenoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Mar 2011 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 8 Apr 2011 (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.
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU | Experimental | Device: Ultrasonic ablation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- One breast fibroadenoma with diagnosis based on:
- Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound)
Key exclusion criteria (7 listed)
- Patient pregnant or lactating
- Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion.
- History of breast cancer or history of laser or radiation therapy to the target breast
- Breast implants
- Breast cyst
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 |
|---|---|---|
| Ultrasonic ablation deviceAlso: TH-OneOne or two HIFU procedures | Device | HIFU |
Primary outcome
Reduction of breast fibroadenoma volume at ultrasonography
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 28331611Kovatcheva R, Zaletel K, Vlahov J, Stoinov J. Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound. 2017 Mar 16;5:1. doi: 10.1186/s40349-017-0083-1. eCollection 2017.
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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, M principal investigator
University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic ablation device in people with Breast Fibroadenoma, 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 6 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
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?
Reduction of breast fibroadenoma volume at ultrasonography (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331954, which also lists 1 linked publication.
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 11 Apr 2024.