The natural history of benign thyroid nodules.
Cosimo Durante, Giuseppe Costante, Giuseppe Lucisano...
https://pubmed.ncbi.nlm.nih.gov/25734734Actively Recruiting
Age: 18Years +
All Genders
ID05189314
Clinical Outcomes and Quality of Life Measures After Surgical Resection and Radiofrequency Ablation of Benign Thyroid Nodules
Led by Columbia University · Updated on 2026-05-29
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate and compare clinical outcomes and quality of life in adults with symptomatic benign multinodular goiter (MNG), a common thyroid condition with nodules that may cause symptoms like swallowing or breathing difficulties. The study focuses on treatments for this condition, including surgical removal and radiofrequency ablation (RFA), a newer technique that uses heat to shrink nodules. These approaches are being studied to understand their effects on symptoms and thyroid function over time. Participants in this observational study include those who undergo either surgical resection of thyroid nodules or radiofrequency ablation. The study collects data before and after treatment to assess outcomes. RFA is guided by ultrasound and is considered investigational in the United States but has been used internationally with positive results. Both treatments are compared to observe changes in nodule size, hormone levels, and symptoms. During the study, participants provide access to their medical information related to their thyroid nodules and treatment outcomes. Researchers will measure changes in nodule volume and thyroid stimulating hormone (TSH) levels at 6 and 12 months after treatment, along with quality of life assessed by the ThyPRO 39 survey at 12 months. The study helps gather long-term data on how these treatments affect thyroid nodules and patient well-being, with participation lasting at least a year.
CONDITIONS
Brief Title
RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years old or older with benign thyroid nodules
You will not qualify if you...
- Cardiac arrhythmia
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Duration of hospital stay and immediate recovery period
Participants who undergo surgical resection of benign thyroid nodules receive surgery and immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Implementation
Duration - Day of the procedure and immediate recovery period
Participants who undergo radiofrequency ablation of benign thyroid nodules receive the procedure and immediate care.
1 procedure visit and follow-up visits as needed
Long-term Monitoring
Duration - Up to 12 months
Participants are monitored for clinical outcomes and quality of life after surgery or radiofrequency ablation.
Visits at 6 months and 12 months post-procedure
Trial Site Locations
Total: 1 location
1
Columbia University
New York, New York, United States, 10032
Actively Recruiting
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Research Team
J
Jennifer H Kuo, MD MS
V
Vilma Rosario
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/29490593