Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules
NCT02714946 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-09-04
Summary
The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.
Conditions
- Thyroid Nodule
Interventions
- DEVICE
-
Percutaneous Radiofrequency Ablation
Single session with standardized approach: A radiofrequency generator and a 17-gauge, 15-cm electrode with a 1-cm active tip will be used. A transisthmic approach along the short axis of the nodule will be used and the nodules will be managed with the moving-shot technique. 60 W of radiofrequency outpower will be used for all nodules. The treatment is performed under local anesthesia and conscious sedation
- DEVICE
-
Percutaneous Laser Ablation
Single session with standardized approach: One or two fibers will be used for treatments including one to three illuminations with a fixed output power of 3 W, using the pullback technique. Energy for each emission will be 1200-1800J based on nodule volume. The treatment is performed under local anesthesia and conscious sedation.
Sponsors & Collaborators
-
Campus Bio-Medico University
lead OTHER
Principal Investigators
-
Roberto Cianni · Santa Maria Goretti Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2019-09-30
- Completion
- 2020-01-31
Countries
- Italy
Study Locations
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