Thyroid NodulesNCT01750593
Radiofrequency Ablation in Thyroid Nodules
A study testing Radiofrequency ablation of the thyroid nodule in people with Thyroid Nodules, run by Bezmialem Vakif University at 3 sites in Turkey (Türkiye).
Trial summary
Thyroid nodules are common problems and although > 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Nodules
- What is being tested?
- Radiofrequency ablation of the thyroid nodule
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- Apr 2013to Jun 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;
- a poor surgical candidate or refusal to undergo surgery;
- fine-needle aspiration cytology and US findings that were compatible with a benign nodule;
- anxiety about a malignancy.
Who cannot join
- a nodule less than 5 mm in size;
- follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);
- a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;
- previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.
Trial locations and contacts
3 sites in 1 country.
Erhan Aysan, Prof. Dr. contact
Yeliz Ersoy, Assoc.Prof contact
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Istanbul, 34308
Erhan Aysan, Prof, 902124531700 ext. 4116, erhanaysan@hotmail.com
Yeliz Ersoy, Assoc. Prof, 902124531700 ext. 4506, yelizemineersoy@yahoo.com
- Recruiting
Bezmialem Vakif University medical Faculty
Istanbul, 34308
Erhan Aysan, Prof. Dr., erhanaysan@hotmail.com
- Recruiting
Bezmialem Vakif University
Istanbul
ERHAN AYSAN, PROF., 902124531700, yelizemineersoy@yahoo.com
About this study
Official title: Efficacy of Radiofrequency Ablation in Thyroid Nodules
Thyroid nodules are common problems and although > 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. Especially for these nodules, patients undergo surgery and face up with the problems associated with surgical complications although they are not cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to use this method in our patients having nodules like previously mentioned and see the efficacy and safety of the technique.
- Conditions
- Thyroid Nodules
- Being tested
- Radiofrequency ablation of the thyroid nodule
- Keywords
- radiofrequency, thyroid, nodule
- Medical subject headings
- Thyroid Nodule, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of the thyroid noduleProcedure or surgery
Under USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm.
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency ablation of thyroid nodule | Experimental | Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation Receives: Procedure: Radiofrequency ablation of the thyroid nodule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shrinkage of the thyroid nodule after radiofrequency ablation
Measured: 6 months
Secondary outcomes (1)
Disappearance of the nodules in follow up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionJan 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NodulesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Emine Ersoy, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750593
- Sponsor's protocol ID
- yelizeminersoy
- Status last verified
- Nov 2013
- First submitted
- 7 Oct 2012
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radiofrequency Ablation in Thyroid Nodules
- ClinicalTrials.gov ID
- NCT01750593
- Acronym / sponsor ID
- yelizeminersoy
- Conditions
- Thyroid Nodules
- Keywords
- radiofrequency, thyroid, nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 17 Dec 2012 (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.
Thyroid nodules are common problems and although > 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. Especially for these nodules, patients undergo surgery and face up with the problems associated with surgical complications although they are not cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to use this method in our patients having nodules like previously mentioned and see the efficacy and safety of the technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiofrequency ablation of thyroid nodule | Experimental | Procedure: Radiofrequency ablation of the thyroid noduleUnder ultrasonography the thyroid nodules will be ablated by radiofrequency ablation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;
- a poor surgical candidate or refusal to undergo surgery;
- fine-needle aspiration cytology and US findings that were compatible with a benign nodule;
- anxiety about a malignancy.
Key exclusion criteria (4 listed)
- a nodule less than 5 mm in size;
- follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);
- a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;
- previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.
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 |
|---|---|---|
| Radiofrequency ablation of the thyroid noduleUnder USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm. | Procedure or surgery | radiofrequency ablation of thyroid nodule |
Primary outcome
Shrinkage of the thyroid nodule after radiofrequency ablation
Time frame: 6 months
1 secondary outcome
Disappearance of the nodules in follow up
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Erhan Aysan, Prof. Dr. contact
Yeliz Ersoy, Assoc.Prof contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation of the thyroid nodule in people with Thyroid Nodules, run by Bezmialem Vakif University at 3 sites in Turkey (Türkiye).
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 4 inclusion and 4 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 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
Contact Erhan Aysan, Prof. Dr. (erhanaysan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shrinkage of the thyroid nodule after radiofrequency ablation (time frame: 6 months). 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 Nov 2013; AzTrials last refreshed its copy on 2 Nov 2026.