Radiofrequency ablation for benign thyroid nodules in LatinX patients
Study of the Use of Radiofrequency Ablation in LatinX Patients With Symptomatic Benign Thyroid Nodules
This study is testing if a new, less invasive treatment called radiofrequency ablation can safely help LatinX patients with bothersome benign thyroid nodules feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05903196 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of radiofrequency ablation (RFA) as a minimally invasive treatment for benign symptomatic thyroid nodules in LatinX patients. Traditionally, surgery was the primary treatment option, but RFA offers a safer alternative that can be performed in a clinic setting without the risks associated with surgery. Participants will undergo the RFA procedure and will be monitored for effectiveness and side effects over 18 months. The study aims to determine if RFA is a safe and effective option for this specific population, which has not been extensively studied before.
Who should consider this trial
Good fit: Ideal candidates are LatinX individuals over 18 years old with benign, symptomatic thyroid nodules that meet specific ultrasound criteria.
Not a fit: Patients with malignant nodules, those who are pregnant or breastfeeding, or individuals with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer, non-surgical option for LatinX patients suffering from symptomatic benign thyroid nodules.
How similar studies have performed: While evidence supporting RFA for thyroid nodules exists internationally, this specific study focusing on LatinX patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
New York, New York
- Northwell Health Physician Partners — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Kuriloff, MD — Northwell Health
- Study coordinator: Karina Ziskovich, BBA
- Email: kziskovich@northwell.edu
- Phone: 212-434-3715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.