Thyroid NoduleNCT05903196
Radiofrequency Ablation Study in LatinX Patients
A study testing Mygen V-1000 RF system in people with Thyroid Nodule, run by Northwell Health at 1 site in United States.
Trial summary
Benign thyroid nodules can still create cosmetic, compressive, or hormonal issues for patients. In the past, surgery was typically used to treat thyroid nodules causing the above issues through partial or complete thyroidectomy. More recently, minimally-invasive techniques have been developed to treat these issues. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Mygen V-1000 RF system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject capable of giving informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Subjects over 18 years of age
- Subject who self-identifies as LatinX
- Subjects who have a benign, symptomatic thyroid nodule
- Subjects whose nodule has well-defined margin on ultrasound and is surrounded by at least 2mm of normal thyroid parenchyma in all directions
Who cannot join
- Patients who are pregnant, trying to become pregnant, or breastfeeding
- Patient who have a cardiac pacemaker,defibrillator , or other electromedical equipment
- Patients who have a nodule that is malignant or not predominantly solid (must be >50% solid by ultrasound)
- Patients who cannot give consent
- Patients on anticoagulation or dual antiplatelet therapy
- Patients with acute illness
- People with BP > 140/90 prior to the scheduled procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwell Health Physician Partners
New York, New York, 10022
Karina Ziskovich, BBA, 212-434-3715, kziskovich@northwell.edu
Jose Sanchez Escobar, MD, 212-434-4972, jsanchez17@northwell.edu
About this study
Official title: Study of the Use of Radiofrequency Ablation in LatinX Patients With Symptomatic Benign Thyroid Nodules
Benign thyroid nodules can still create cosmetic, compressive, or hormonal issues for patients. In the past, surgery was typically used to treat thyroid nodules causing the above issues through partial or complete thyroidectomy. More recently, minimally-invasive techniques have been developed to treat these issues. This study is investigating the use of one of these techniques, radiofrequency ablation, in Latinx patients with benign symptomatic thyroid nodules. This procedure is of interest because it avoids the risks of surgery and can be done outside an operating room. The study hypothesis is that the use of RFA is an effective and safe therapeutic option for LatinX patients with a symptomatic benign nodule wishing to avoid surgery.
Read the detailed description
Thyroid nodules can create issues for individuals such as affecting the level of their thyroid hormones, causing an unwanted physical appearance, or pressing on other important structures in the neck (for example, trachea and esophagus). In the past, surgery was typically used to treat thyroid nodules causing the above issues, either taking out some or all of the thyroid. More recently, new techniques that do not require surgery have been developed to treat these issues. This study is investigating the use of one of these newer techniques, called radiofrequency ablation in Latinx patients with non-cancerous symptomatic thyroid nodules. This procedure is of interest because it avoids the risks of surgery (like bleeding, infection, scars) and can be done in a clinic setting. The theory is that this procedure will be a safe and effective alternative to surgery for non-cancerous thyroid nodules that are causing symptoms in Latinx patients, which is a population in which this treatment has not yet been studied. Patients who decide to enroll in the study will be required to fill out questionnaires, have blood tests, have ultrasounds of the thyroid, and undergo the radiofrequency ablation minimally-invasive treatment instead of surgery. Patients will be evaluated at 1 month, 3 months, 6 months, 12 months, and 18 months after the procedure to assess for effectiveness of the procedure and any side effects.
Most evidence supporting RFA of thyroid nodules comes from international cohorts. In a recent meta-analysis, RFA accomplished volume reduction ranging from 68 to 87% in over 1100 treated nodules. This reduction was sustained for up to 5 years. In terms of its safety, a recent systematic review of 2700 nodules showed only 41 major complications and 48 minor complications from RFA. Of note, most complications were transient, only 4 patients developed permanent voice changes, while 1 required rescue lobectomy after a nodule ruptured. Published data in the United States also showed RFA to be an effective and safe strategy. However, of the 47 studied patients, none were LatinX. Furthermore, lack of coverage by insurance companies means this procedure is typically only available as an out-of-pocket expense and is therefore out of reach for underserved patients. Data to establish the safety/feasibility of this novel intervention is needed for the LatinX population.
- Conditions
- Thyroid Nodule
- Being tested
- Mygen V-1000 RF system
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mygen V-1000 RF systemDevice
The Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation \& ablation of vessel, tissue \& bone
| Study group | Role | What they receive |
|---|---|---|
| Mygen V-1000 RF system | Experimental | The Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation \& ablation of vessel, tissue \& bone Receives: Device: Mygen V-1000 RF system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related changes in thyroid nodule volumes
To study the change in nodule volume
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start12 Mar 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Kuriloff, Northwell Health
- Investigators
- Daniel Kuriloff, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903196
- Sponsor's protocol ID
- 22-0711
- Status last verified
- Sep 2025
- First submitted
- 19 May 2023
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Use of Radiofrequency Ablation in LatinX Patients With Symptomatic Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT05903196
- Acronym / sponsor ID
- 22-0711
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Jun 2023 (actual)
- 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.
Benign thyroid nodules can still create cosmetic, compressive, or hormonal issues for patients. In the past, surgery was typically used to treat thyroid nodules causing the above issues through partial or complete thyroidectomy. More recently, minimally-invasive techniques have been developed to treat these issues. This study is investigating the use of one of these techniques, radiofrequency ablation, in Latinx patients with benign symptomatic thyroid nodules. This procedure is of interest because it avoids the risks of surgery and can be done outside an operating room. The study hypothesis is that the use of RFA is an effective and safe therapeutic option for LatinX patients with a symptomatic benign nodule wishing to avoid surgery.
Detailed description
Thyroid nodules can create issues for individuals such as affecting the level of their thyroid hormones, causing an unwanted physical appearance, or pressing on other important structures in the neck (for example, trachea and esophagus). In the past, surgery was typically used to treat thyroid nodules causing the above issues, either taking out some or all of the thyroid. More recently, new techniques that do not require surgery have been developed to treat these issues. This study is investigating the use of one of these newer techniques, called radiofrequency ablation in Latinx patients with non-cancerous symptomatic thyroid nodules. This procedure is of interest because it avoids the risks of surgery (like bleeding, infection, scars) and can be done in a clinic setting. The theory is that this procedure will be a safe and effective alternative to surgery for non-cancerous thyroid nodules that are causing symptoms in Latinx patients, which is a population in which this treatment has not yet been studied. Patients who decide to enroll in the study will be required to fill out questionnaires, have blood tests, have ultrasounds of the thyroid, and undergo the radiofrequency ablation minimally-invasive treatment instead of surgery. Patients will be evaluated at 1 month, 3 months, 6 months, 12 months, and 18 months after the procedure to assess for effectiveness of the procedure and any side effects.
Most evidence supporting RFA of thyroid nodules comes from international cohorts. In a recent meta-analysis, RFA accomplished volume reduction ranging from 68 to 87% in over 1100 treated nodules. This reduction was sustained for up to 5 years. In terms of its safety, a recent systematic review of 2700 nodules showed only 41 major complications and 48 minor complications from RFA. Of note, most complications were transient, only 4 patients developed permanent voice changes, while 1 required rescue lobectomy after a nodule ruptured. Published data in the United States also showed RFA to be an effective and safe strategy. However, of the 47 studied patients, none were LatinX. Furthermore, lack of coverage by insurance companies means this procedure is typically only available as an out-of-pocket expense and is therefore out of reach for underserved patients. Data to establish the safety/feasibility of this novel intervention is needed for the LatinX population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mygen V-1000 RF system | Experimental | Device: Mygen V-1000 RF systemThe Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation \& ablation of vessel, tissue \& bone |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject capable of giving informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Subjects over 18 years of age
- Subject who self-identifies as LatinX
- Subjects who have a benign, symptomatic thyroid nodule
Key exclusion criteria (7 listed)
- Patients who are pregnant, trying to become pregnant, or breastfeeding
- Patient who have a cardiac pacemaker,defibrillator , or other electromedical equipment
- Patients who have a nodule that is malignant or not predominantly solid (must be >50% solid by ultrasound)
- Patients who cannot give consent
- Patients on anticoagulation or dual antiplatelet 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 |
|---|---|---|
| Mygen V-1000 RF systemThe Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation \& ablation of vessel, tissue \& bone | Device | Mygen V-1000 RF system |
Primary outcome
Number of participants with treatment-related changes in thyroid nodule volumes
Time frame: 2 years
To study the change in nodule volume
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Kuriloff, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mygen V-1000 RF system in people with Thyroid Nodule, run by Northwell Health at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karina Ziskovich, BBA (212-434-3715, kziskovich@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related changes in thyroid nodule volumes (time frame: 2 years). 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 23 Sep 2025.