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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Northwell Health Physician Partners
RECRUITING
New York
Contact Information
Primary
Karina Ziskovich, BBA
kziskovich@northwell.edu
212-434-3715
Backup
Jose Sanchez, MD
jsanchez17@northwell.edu
212-434-4972
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 44
Treatments
Experimental: 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
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov