Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules, using EchoLaser, results of a pilot study in the US

BackgroundThyroid nodules are associated with significant symptoms and currently, surgery is the primary management option for symptomatic nodules. This can result in complications and cosmetic disfigurement. Laser ablation is an alternative treatment option. We conducted a single-center, prospective, non-randomized, open-label, interventional pilot study to evaluate the effects of a single ultrasound-guided laser ablation treatment on symptomatic benign thyroid nodules in an outpatient setting.Materials and MethodsThis study included adults with normal thyroid function and symptomatic thyroid nodules measuring > 29 mm and ≤60 mm with <20% cystic area by ultrasound. Laser ablation energy was calculated based on device guidelines. A single nodule was treated under local anesthesia. Each application session lasted between 400 and 600 seconds under a laser power output of 3W.Results10 subjects underwent the study procedure and 9 subjects completed 12-month follow up. Baseline thyroid nodule volumes ranged from 5.51-28.22 ml and total energy delivered ranged from 1477.00-7206.50 J. The average nodule volume reduction at 12 months post-procedure for 9 patients was 71.087%. Nodules were visible from >1 meter away at baseline for all 10 subjects, and not visible in 8/10 at 3 months and 6/9 at 12 months. Most subjects reported they would likely undergo the procedure again. No significant adverse events were reported.ConclusionThis study demonstrated the feasibility of performing laser ablation in a clinic setting in the United States. Reduction in nodule volume and symptoms were observed, and the procedure was well-tolerated by the subjects.