A Phase 4 interventional study of Percutaneous Laser Ablation in Thyroid Nodule, sponsored by Elesta S.R.L.. Completed at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-26.
Sponsored by Elesta S.R.L. · Phase 4, Interventional, and Treatment
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:
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.
200 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.
This study's enrollment of 200 is above the median of 81 across 118 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →This is the only study on the registry with Elesta S.R.L. as lead sponsor.
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Exclusion Criteria:
Laser thermal ablation
Procedure: Percutaneous Laser Ablation
Follow-up
Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.
Also known as: Arcispedale S. Maria Nuova is using commercially available system EchoLaser XVG, (Integrated Ultrasound-Laser, Elesta, Italy). Other centers are using commercially available, systems MyLab70XV (Ultrasound, Esaote, Italy) and Smart1064 BS (Nd:Yag Laser,, DEKA, Italy). Disposable Fiber Optic devices : Bare Fiber PLA THY 2111, Bare Fiber PLA S, (Asclepion Laser Technologies GmbH, Germany).
Short- (1-year) and long- (3-year) term evolution of the thyroid nodules volume and symptoms after the treatment vs. simple clinical observation.(Strong Endpoint: %nodules with greater than 50% base volume reduction and %patients free of symptoms)
Time frame: 3 years
Assessment of short-term and long-term PLA safety, tolerability and reproducibility.
Time frame: 3 years
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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