Clinical trial · Interventional
Effect of Ultrasound Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules
NCT04277455CI-TRIAL-00077670completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser ablation of benign thyroid nodule | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Patients will receive laser treatment for benign symptomatic nodules
- interventionNames
- Device: Laser ablation of benign thyroid nodule
Primary outcomes (5)
- measure
- Change in Radiographic Volume of Thyroid Nodule From Baseline at 3, 6 and 12 Months After Laser Ablation
- timeFrame
- 12 months
- description
- Percentage change from baseline volume will be calculated at 3, 6 and 12 months after laser treatment.
- measure
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDPacella CM, Mauri G, Achille G, Barbaro D, Bizzarri G, De Feo P, Di Stasio E, Esposito R, Gambelunghe G, Misischi I, Raggiunti B, Rago T, Patelli GL, D'Este S, Vitti P, Papini E. Outcomes and Risk Factors for Complications of Laser Ablation for Thyroid Nodules: A Multicenter Study on 1531 Patients. J Clin Endocrinol Metab. 2015 Oct;100(10):3903-10. doi: 10.1210/jc.2015-1964. Epub 2015 Aug 14. PMID 26274342
- BACKGROUNDPapini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. Long-term efficacy of ultrasound-guided laser ablation for benign solid thyroid nodules. Results of a three-year multicenter prospective randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3653-9. doi: 10.1210/jc.2014-1826. Epub 2014 Jul 22. PMID 25050903
- BACKGROUNDPacella CM, Mauri G, Cesareo R, Paqualini V, Cianni R, De Feo P, Gambelunghe G, Raggiunti B, Tina D, Deandrea M, Limone PP, Mormile A, Giusti M, Oddo S, Achille G, Di Stasio E, Misischi I, Papini E. A comparison of laser with radiofrequency ablation for the treatment of benign thyroid nodules: a propensity score matching analysis. Int J Hyperthermia. 2017 Dec;33(8):911-919. doi: 10.1080/02656736.2017.1332395. Epub 2017 Jun 12. PMID 28605944