RECRUITINGINTERVENTIONAL

Radiofrequency Ablation Study in LatinX Patients

Study of the Use of Radiofrequency Ablation in LatinX Patients With Symptomatic Benign Thyroid Nodules

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Subject capable of giving willing to sign a consent form - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Mygen V-1000 RF system

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

Locations (1)

Northwell Health Physician Partners

New York, New York, United States