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Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules

CompletedNA

Sponsor: Johnson Thomas

Conditions: Thyroid Nodule

Interventions: Laser ablation of benign thyroid nodule

Countries: United States

This is a prospective trial to evaluate the effects of laser ablation on symptomatic benign thyroid nodules. The study is designed to assess the clinical efficacy, safety, tolerability and impact on symptoms of single ultrasound guided laser ablation treatment of symptomatic benign thyroid nodules. Approximately 20 subjects will undergo laser ablation of symptomatic benign nodules.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Males or females, Age ≥18 years
* Thyroid Stimulating Hormone (TSH) within normal limits
* Presence of thyroid nodule \>29 mm and ≤60 mm in the longest dimension on ultrasound imaging
* Symptoms from thyroid nodule - tightness or pressure in neck, neck tenderness, neck pain, difficulty swallowing, voice changes, shortness of breath or cosmetic disfigurement
* Solid thyroid nodule with less than 20% cystic component
* Cytological benign nodule proven by previous biopsy within 2 years
* Ability to place the laser tip inside the nodule and to keep vital structures (i.e. trachea and esophagus) outside the zone of injury. To achieve this safe zone, we will leave a minimum of 17 mm distance between the fiber tip anterior to the vital structures and 10 mm from the fiber tip in all other dimensions.
* Not on anticoagulants or anticoagulants stopped for appropriate amount of time based on the pharmacology of the drug
* Ability to understand and willingness to provide informed consent

Exclusion Criteria:

* Pregnancy
* Diagnosis of Hyperthyroidism
* Malignant thyroid nodule
* Egg shell or coarse calcification in the thyroid nodule
* Patient on anticoagulation which cannot be stopped due to medical reasons
* Coagulopathy
* Thyroid nodules in contact with trachea, esophagus or major blood vessels
* Prior neck surgery
* Prior radiation to head and neck
* Previous radioactive iodine treatment
* Current iodine supplementation
* Current anti-thyroid medication
* Biotin supplementation within 2 days prior to enrollment
* Allergy to Ethyl chloride spray or lidocaine
* Physical and psychological conditions that prevent safe administration of the procedure as determined by the investigator
* Adults not able to consent
* Prisoners
* Individuals who cannot read and understand English

Locations (1)

Springfield, Missouri, United States