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Spots Global Cancer Trial Database for Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

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Trial Identification

Brief Title: Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

Official Title: Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results

Study ID: NCT00858104

Conditions

Thyroid Nodule

Study Description

Brief Summary: Thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. The majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term levothyroxine treatment has, however, several well-known side effects and limitations. During the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects. Aim of the study: 1. to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign thyroid nodules and on nodule-related symptoms, and to compare these effects with findings in control group without active therapy; 2. to assess the eventual re-occurence of thyroid lesions (observed after other types of ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up; 3. to demonstrate reproducibility of results within different environments and under different operators; 4. to validate eventual presence of major or minor side effects. To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up. Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ospedale Regina Apostolorum, Albano Laziale, Roma, Italy

Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia, Perugia, , Italy

Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello, Pisa, , Italy

Arcispedale S. Maria Nuova, Reggio Emilia, , Italy

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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