Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules (NCT04277455) | Clinical Trial Compass
CompletedNot Applicable
Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
United States10 participantsStarted 2020-10-26
Plain-language summary
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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Bioti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation
Timeframe: 12 months
2
Change in the Thyroid Function After Laser Treatment Assessed by the Measurement of TSH and Free T4 at 3, 6 and 12 Months After Laser Ablation
Timeframe: 12 months
3
Change in Doppler Grade at 3, 6, and 12 Months After Laser Ablation
Timeframe: 12 months
4
Change in Thyroid Antibody Levels 3,6 and 12 Months After Laser Ablation
Timeframe: 12 months
5
Cosmetic Assessment at 3,6 and 12 Months and Immediately After Laser Ablation Measured Using a Numerical Scale
Timeframe: 3 months, 6 months, and 12 months after procedure